Federal Register Vol. 83, No.204,
Federal Register Volume 83, Issue 204 (October 22, 2018)
Federal Register Volume 83, Issue 204 (October 22, 2018)
| Page Range | 53159-53361 | |
| FR Document |
Document Created: 2017-12-29 23:38:26
Document Modified: 2017-12-29 23:38:26
| Page and Subject | |
|---|---|
| 83 FR 53248 - Sunshine Act Meeting | |
| 83 FR 53295 - Government in the Sunshine Act Meeting Notice | |
| 83 FR 53352 - Plexus Fund IV-B, L.P.; Notice Seeking Exemption Under the Small Business Investment Act, Conflicts of Interest | |
| 83 FR 53351 - Plexus Fund IV-C, L.P.; Notice Seeking Exemption Under the Small Business Investment Act, Conflicts of Interest | |
| 83 FR 53352 - Plexus Fund IV-A, L.P.; Notice Seeking Exemption Under the Small Business Investment Act, Conflicts of Interest | |
| 83 FR 53355 - Overseas Security Advisory Council (OSAC) Renewal | |
| 83 FR 53294 - Request for Nominations for the Gateway National Recreation Area Fort Hancock 21st Century Advisory Committee | |
| 83 FR 53293 - Request for Nominations for the Made in America Outdoor Recreation Advisory Committee | |
| 83 FR 53355 - Overseas Security Advisory Council (Osac) Meeting Notice; Closed Meeting | |
| 83 FR 53195 - Airline Transport Pilot and Type Rating for Airplane Airman Certification Standards | |
| 83 FR 53356 - Petition for Exemption; Summary of Petition Received; Latitude Engineering, LLC | |
| 83 FR 53357 - Notice of Intent To Rule on Disposal of Aeronautical Property at Murfreesboro Municipal Airport, Murfreesboro, TN | |
| 83 FR 53356 - Petition for Exemption; Summary of Petition Received; Sprayt Robotics | |
| 83 FR 53358 - Correction to Notice of Availability (NOA) for Consensus Standards, Light-Sport Aircraft, Notice No. NOA-18-01 | |
| 83 FR 53250 - General Services Administration Acquisition Regulation (GSAR); Submission for OMB Review; Environmental Conservation, Occupational Safety, and Drug-Free Workplace | |
| 83 FR 53290 - Agency Information Collection Activities; Homeliving Programs and School Closure and Consolidation | |
| 83 FR 53196 - Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption; Draft Guidance for Industry; Availability | |
| 83 FR 53197 - Guide To Minimize Food Safety Hazards of Fresh-Cut Produce: Draft Guidance for Industry; Availability | |
| 83 FR 53241 - Certain New Chemical Substances; Receipt and Status Information for July 2018 | |
| 83 FR 53241 - Meeting of the Mobile Sources Technical Review Subcommittee | |
| 83 FR 53288 - 60-Day Notice of Proposed Information Collection: Revitalization Area Designation and Management | |
| 83 FR 53282 - Statutorily Mandated Designation of Difficult Development Areas and Qualified Census Tracts for 2019 | |
| 83 FR 53183 - National Emission Standards for Hazardous Air Pollutants; Delegation of Authority to Oklahoma | |
| 83 FR 53341 - Procure Active ETF Trust, et al. | |
| 83 FR 53233 - Information Collection Requirement; Defense Federal Acquisition Regulation Supplement (DFARS); Contract Financing | |
| 83 FR 53334 - Procure ETF Trust I, et al. | |
| 83 FR 53216 - Gulf of Mexico Fishery Management Council; Public Meeting | |
| 83 FR 53232 - Fisheries of the South Atlantic; Southeast Data, Assessment, and Review (SEDAR); Public Meeting | |
| 83 FR 53253 - Assisted Reproductive Technology (ART) Success Rates Reporting and Data Validation Procedures | |
| 83 FR 53231 - South Atlantic Fishery Management Council; Public Meetings | |
| 83 FR 53358 - Pipeline Safety: Information Collection Activities; Revision of the Hazardous Liquid Annual Report | |
| 83 FR 53256 - Mine Safety and Health Research Advisory Committee (MSHRAC) | |
| 83 FR 53251 - Board of Scientific Counselors, National Center for Health Statistics (BSC, NCHS) | |
| 83 FR 53317 - Exelon Generation Company, LLC; Oyster Creek Nuclear Generating Station Request for Exemptions Regarding Emergency Planning Requirements | |
| 83 FR 53321 - Southern Nuclear Operating Company, Inc.; Vogtle Electric Generating Plant, Units 3 and 4; Inspections, Tests, Analyses, and Acceptance Criteria | |
| 83 FR 53297 - Notice of Lodging of Proposed Consent Decree Under the Comprehensive Environmental Response, Compensation, and Liability Act | |
| 83 FR 53315 - Southern Nuclear Operating Company, Inc.; Vogtle Electric Generating Plant, Units 3 and 4; Containment Sump Level Instrumentation | |
| 83 FR 53351 - Presidential Declaration of a Major Disaster for Public Assistance Only for the Commonwealth of Virginia | |
| 83 FR 53351 - Presidential Declaration Amendment of a Major Disaster for the State of Florida | |
| 83 FR 53292 - Notice of Availability of the Draft Environmental Impact Statement for the Proposed Deep South Expansion Project, Lander and Eureka Counties, Nevada | |
| 83 FR 53291 - Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Donor Certification Form | |
| 83 FR 53264 - Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 050 | |
| 83 FR 53204 - The Safer Affordable Fuel-Efficient (SAFE) Vehicles Rule for Model Years 2021-2026 Passenger Cars and Light Trucks | |
| 83 FR 53355 - Release of Waybill Data | |
| 83 FR 53212 - Export Trade Certificate of Review | |
| 83 FR 53190 - Expanding the Economic and Innovation Opportunities of Spectrum Through Incentive Auctions; Office of Engineering and Technology Releases and Seeks Comment on Updated OET-69 Software; Office of Engineering and Technology Seeks To Supplement the Incentive Auction Proceeding Record Regarding Potential Interference Between Broadcast Television and Wireless Services | |
| 83 FR 53212 - University of California, Berkeley et al.; Notice of Decision on Application for Duty-Free Entry of Scientific Instruments | |
| 83 FR 53212 - Foreign-Trade Zone 168-Dallas/Fort Worth, Texas, Area; Application for Subzone; Schumacher Electric Corporation; Fort Worth, Texas | |
| 83 FR 53352 - Agency Information Collection Activities: Proposed Request and Comment Request | |
| 83 FR 53214 - Certain Activated Carbon From the People's Republic of China: Final Results of Antidumping Duty Administrative Review; 2016-2017 | |
| 83 FR 53289 - Endangered and Threatened Species; Receipt of Recovery Permit Applications | |
| 83 FR 53361 - Notice of Stakeholder Roundtable on Coin Circulation | |
| 83 FR 53235 - Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Federal Family Educational Loan Program-Servicemembers Civil Relief Act (SCRA) | |
| 83 FR 53234 - Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Servicemembers Civil Relief Act (SCRA): Interest Rate Limitation Request | |
| 83 FR 53295 - Forged Steel Fittings From China and Italy; Scheduling of the Final Phase of Antidumping and Countervailing Duty Investigations | |
| 83 FR 53257 - Agency Information Collection Activities; Proposed Collection; Comment Request; Collection of Conflict of Interest Information for Participation in Food and Drug Administration Non-Employee Fellowship and Traineeship Programs | |
| 83 FR 53275 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Draft Guidance for Industry: Labeling of Red Blood Cell Units With Historical Antigen Typing Results | |
| 83 FR 53273 - Determination of Regulatory Review Period for Purposes of Patent Extension; BESPONSA | |
| 83 FR 53259 - Determination of Regulatory Review Period for Purposes of Patent Extension; TECENTRIQ | |
| 83 FR 53260 - Determination of Regulatory Review Period for Purposes of Patent Extension; TYMLOS | |
| 83 FR 53262 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Formal Meetings With Sponsors and Applicants for Prescription Drug User Fee Act Products | |
| 83 FR 53271 - Agency Information Collection Activities; Proposed Collection; Comment Request; Foreign Supplier Verification Programs for Food Importers | |
| 83 FR 53276 - National Committee on Vital and Health Statistics: Hearing | |
| 83 FR 53207 - Solicitation of Veterinary Shortage Situation Nominations for the Veterinary Medicine Loan Repayment Program (VMLRP) | |
| 83 FR 53237 - Winter 2018-2019 Operations and Market Performance in Regional Transmission Organizations and Independent System Operators; Supplemental Notice of Technical Conference | |
| 83 FR 53240 - Combined Notice of Filings | |
| 83 FR 53355 - Notice of Determinations; Culturally Significant Objects Imported for Exhibition-Determinations: “The Jeweled Isle: Art From Sri Lanka” Exhibition | |
| 83 FR 53237 - Pacific Gas and Electric Company; Notice of Application Accepted for Filing and Soliciting Comments, Motions To Intervene, and Protests | |
| 83 FR 53241 - Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization: Birdsboro Power LLC | |
| 83 FR 53238 - Combined Notice of Filings #1 | |
| 83 FR 53239 - Records Governing Off-The-Record Communications Public Notice | |
| 83 FR 53337 - Investor Advisory Committee Meeting | |
| 83 FR 53257 - Allergenic Products Advisory Committee; Cancellation | |
| 83 FR 53361 - Enhanced-Use Lease (EUL) of U.S. Department of Veterans Affairs (VA) Real Property for the Development of a Permanent Supportive Housing Facility at the Lexington VA Health Care System, Franklin R. Sousley Campus in Lexington, Kentucky | |
| 83 FR 53252 - Proposed Data Collection Submitted for Public Comment and Recommendations | |
| 83 FR 53256 - Agency Forms Undergoing Paperwork Reduction Act Review | |
| 83 FR 53211 - Agenda and Notice of Public Meeting of the Rhode Island Advisory Committee | |
| 83 FR 53163 - Special Conditions: The Boeing Company (Boeing), Model 777 Series Airplanes; Dynamic Test Requirements for Single Occupant Oblique Seats, With or Without Airbag Devices or 3-Point Restraints | |
| 83 FR 53358 - Petition for Exemption; Summary of Petition Received; Corvus Airlines dba Ravn Alaska | |
| 83 FR 53326 - Securities Exchange Act of 1934; Release No. 34-84440/October 16, 2018; Investment Company Act of 1940; Release No. IC-33272/October 16, 2018; Order Under Section 15b, Section 17a and Section 36 of the Securities Exchange Act of 1934 Granting Exemptions From Specified Provisions of the Exchange Act and Certain Rules Thereunder; Order Under Section 6(C) and Section 38(A) of the Investment Company Act of 1940 Granting Exemptions From Specified Provisions of the Investment Company Act and Certain Rules Thereunder | |
| 83 FR 53168 - Special Conditions: Bombardier, Inc., BD-700-2A12 and BD-700-2A13 Airplanes; Multiple-Place Side-Facing Seats With Active Leg-Flail Restraint Device and Shoulder-Belt Airbags | |
| 83 FR 53193 - Special Conditions: Gulfstream Aerospace Corporation Model GVII-G500 Airplanes; Airbag Systems on Multiple-Place and Single-Place Side-Facing Seats | |
| 83 FR 53356 - Petition for Exemption; Summary of Petition Received; Bombardier Inc.; Correction | |
| 83 FR 53210 - Notice of Public Meeting of the Michigan Advisory Committee | |
| 83 FR 53297 - Notice Pursuant to the National Cooperative Research and Production Act of 1993-National Fire Protection Association | |
| 83 FR 53240 - City of Alexandria, Louisiana v. Cleco Power LLC; Notice of Complaint | |
| 83 FR 53217 - Takes of Marine Mammals Incidental to Specified Activities; Taking Marine Mammals Incidental to the Mission Bay Ferry and Water Taxi Landing Project in San Francisco Bay, California | |
| 83 FR 53166 - Special Conditions: Mitsubishi Aircraft Corporation Model MRJ-200 Airplane; Passenger Seats With Non-Traditional, Large, Non-Metallic Panels | |
| 83 FR 53294 - Clad Steel Plate From Japan; Cancellation of Hearing for Full Five-Year Review | |
| 83 FR 53296 - Certain Road Milling Machines and Components Thereof; Notice of Request for Statements on the Public Interest | |
| 83 FR 53312 - Investigations Regarding Eligibility To Apply for Worker Adjustment Assistance | |
| 83 FR 53313 - Agency Information Collection Activities: Announcement of the Office of Management and Budget (OMB) Control Numbers Under the Paperwork Reduction Act | |
| 83 FR 53297 - Notice of Determinations Regarding Eligibility To Apply for Trade Adjustment Assistance | |
| 83 FR 53301 - Post-Initial Determinations Regarding Eligiblity To Apply for Trade Adjustment Assistance | |
| 83 FR 53248 - Proposed Agency Information Collection Activities; Comment Request | |
| 83 FR 53191 - List of Approved Spent Fuel Storage Casks: NAC International NAC-UMS®; Universal Storage System, Certificate of Compliance No. 1015, Amendment No. 6 | |
| 83 FR 53159 - List of Approved Spent Fuel Storage Casks: NAC International NAC-UMS® Universal Storage System, Certificate of Compliance; No. 1015, Amendment No. 6 | |
| 83 FR 53199 - Safety Zone; Delaware River; Camden, NJ; Fireworks Display | |
| 83 FR 53339 - Self-Regulatory Organizations; The Nasdaq Stock Market LLC; Notice of Designation of a Longer Period for Commission Action on Proposed Rule Change To List and Trade Corporate Non-Convertible Bonds on Nasdaq | |
| 83 FR 53343 - Self-Regulatory Organizations; Cboe BZX Exchange, Inc.; Notice of Filing of a Proposed Rule Change To List and Trade Shares of the FormulaFolios Sector Rotation ETF, a Series of the Northern Lights Fund Trust IV, Under Rule 14.11(i), Managed Fund Shares | |
| 83 FR 53336 - Self-Regulatory Organizations; Cboe Exchange, Inc.; Order Approving a Proposed Rule Change To Amend Exchange Rule 6.49A, Transfer of Positions | |
| 83 FR 53337 - Self-Regulatory Organizations; Cboe Exchange, Inc.; Order Approving a Proposed Rule Change To Amend Rule 6.2, Interpretation and Policy .01, Concerning Strategy Orders | |
| 83 FR 53339 - Self-Regulatory Organizations; Fixed Income Clearing Corporation; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Allow CCIT Members To Elect To Pay Their Funds-Only Settlement Amount Debits Using a Different Process | |
| 83 FR 53324 - Self-Regulatory Organizations; New York Stock Exchange LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change of Non-Substantive Amendments to Rules 1.1, 7.31, and 7.46 | |
| 83 FR 53349 - Self-Regulatory Organizations; Cboe EDGX Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change Related to Fees for Use on Cboe EDGX Exchange, Inc. | |
| 83 FR 53347 - Self-Regulatory Organizations; NYSE National, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend Its Schedule of Fees To Adopt the Same Billing Dispute Practice as the Exchange's Affiliates and Other Exchanges | |
| 83 FR 53277 - National Center for Complementary and Integrative Health; Notice of Meeting | |
| 83 FR 53276 - National Heart, Lung, and Blood Institute; Notice of Closed Meetings | |
| 83 FR 53279 - National Institute on Deafness and Other Communication Disorders; Notice of Closed Meeting | |
| 83 FR 53278 - Center for Scientific Review; Notice of Closed Meeting | |
| 83 FR 53277 - Center for Scientific Review; Notice of Closed Meetings | |
| 83 FR 53279 - National Library of Medicine; Notice of Closed Meetings | |
| 83 FR 53360 - Notice of OFAC Sanctions Action | |
| 83 FR 53315 - Notice of Information Collection | |
| 83 FR 53329 - Blackstone Real Estate Income Fund, et al. | |
| 83 FR 53211 - Agenda and Notice of Public Meeting of the District of Columbia Advisory Committee | |
| 83 FR 53179 - Presumption of Herbicide Exposure and Presumption of Disability During Service for Reservists Presumed Exposed to Herbicides | |
| 83 FR 53351 - Presidential Declaration Amendment of a Major Disaster for the State of North Carolina | |
| 83 FR 53281 - Notice of Adjustment of Disaster Grant Amounts | |
| 83 FR 53280 - Notice of Adjustment of Minimum Project Worksheet Amount | |
| 83 FR 53279 - Notice of Adjustment of Statewide per Capita Impact Indicator | |
| 83 FR 53279 - Notice of Adjustment of Countywide per Capita Impact Indicator | |
| 83 FR 53282 - Florida; Emergency and Related Determinations | |
| 83 FR 53281 - Notice of Maximum Amount of Assistance Under the Individuals and Households Program | |
| 83 FR 53280 - National Advisory Council; Meeting | |
| 83 FR 53359 - Notice of OFAC Sanctions Actions | |
| 83 FR 53236 - Environmental Management Site-Specific Advisory Board, Northern New Mexico | |
| 83 FR 53206 - Submission for OMB Review; Comment Request | |
| 83 FR 53235 - State Energy Advisory Board | |
| 83 FR 53236 - Environmental Management Site-Specific Advisory Board, Nevada | |
| 83 FR 53206 - Codex Alimentarius Commission: Meeting of the Codex Committee on Spices and Culinary Herbs | |
| 83 FR 53233 - Multistakeholder Process on Promoting Software Component Transparency | |
| 83 FR 53322 - Excepted Service | |
| 83 FR 53171 - Airworthiness Directives; Bell Helicopter Textron Canada Limited Helicopters | |
| 83 FR 53201 - Air Plan Approval; ID, West Silver Valley PM2.5 | |
| 83 FR 53177 - Standard Instrument Approach Procedures, and Takeoff Minimums and Obstacle Departure Procedures; Miscellaneous Amendments | |
| 83 FR 53174 - Standard Instrument Approach Procedures, and Takeoff Minimums and Obstacle Departure Procedures; Miscellaneous Amendments |
Issue
National Institute of Food and Agriculture
The U.S. Codex Office
Foreign-Trade Zones Board
International Trade Administration
National Oceanic and Atmospheric Administration
National Telecommunications and Information Administration
Defense Acquisition Regulations System
Federal Energy Regulatory Commission
Centers for Disease Control and Prevention
Food and Drug Administration
National Institutes of Health
Coast Guard
Federal Emergency Management Agency
Fish and Wildlife Service
Indian Affairs Bureau
Land Management Bureau
National Park Service
Antitrust Division
Employment and Training Administration
Occupational Safety and Health Administration
Federal Aviation Administration
National Highway Traffic Safety Administration
Pipeline and Hazardous Materials Safety Administration
Foreign Assets Control Office
United States Mint
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Nuclear Regulatory Commission.
Direct final rule.
The U.S. Nuclear Regulatory Commission (NRC) is amending its spent fuel storage regulations by revising the NAC International NAC-UMS® listing within the “List of approved spent fuel storage casks” to include Amendment No. 6 to Certificate of Compliance (CoC) No. 1015. Amendment No. 6 revises the CoC's technical specifications (TSs) to: Remove a redundant requirement for inspection of the concrete cask and canister; revise a limiting condition of operation (LCO) for heat removal to clarify that “LCO not met” means that the concrete heat removal system is inoperable; remove an inspection requirement that is already covered by LCO surveillance requirements for off-normal, accident, or natural phenomenon events; and clarify that “immediate” restoration of a concrete cask's heat removal capabilities means “within the design-basis time limit” in Section 11.2.13 of the Final Safety Analysis Report (FSAR), “or within the time limit for a less than design-basis heat load case, as evaluated.” Amendment No. 6 also clarifies that an LCO for loaded cask surface dose rates applies prior to storage conditions, when dose rates will be highest.
This direct final rule is effective January 7, 2019, unless significant adverse comments are received by November 21, 2018. If this direct final rule is withdrawn as a result of such comments, timely notice of the withdrawal will be published in the
You may submit comments by any of the following methods:
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For additional direction on obtaining information and submitting comments, see “Obtaining Information and Submitting Comments” in the
Bernard H. White, Office of Nuclear Material Safety and Safeguards; telephone: 301-415-6577; email:
Please refer to Docket ID NRC-2018-0075 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:
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Please include Docket ID NRC-2018-0075 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 direct final rule is limited to the changes contained in Amendment No. 6 to CoC No. 1015 and does not include other aspects of the NAC-UMS® Universal Storage System design. The NRC is using the “direct final rule procedure” to issue this amendment because it represents a limited and routine change to an existing CoC that is expected to be noncontroversial. Adequate protection of public health and safety continues to be ensured. The amendment to the rule will become effective on January 7, 2019. However, if the NRC receives significant adverse comments on this direct final rule by November 21, 2018, then the NRC will publish a document that withdraws this action and will subsequently address the comments received in a final rule as a response to the companion proposed rule published in the Proposed Rules section of this issue of the
A significant adverse comment is a comment where the commenter explains why the rule would be inappropriate, including challenges to the rule's underlying premise or approach, or would be ineffective or unacceptable without a change. A comment is adverse and significant if:
(1) The comment opposes the rule and provides a reason sufficient to require a substantive response in a notice-and-comment process. For example, a substantive response is required when:
(a) The comment causes the NRC to reevaluate (or reconsider) its position or conduct additional analysis;
(b) The comment raises an issue serious enough to warrant a substantive response to clarify or complete the record; or
(c) The comment raises a relevant issue that was not previously addressed or considered by the NRC.
(2) The comment proposes a change or an addition to the rule, and it is apparent that the rule would be ineffective or unacceptable without incorporation of the change or addition.
(3) The comment causes the NRC to make a change (other than editorial) to the rule, CoC, or TSs.
For detailed instructions on filing comments, please see the companion proposed rule published in the Proposed Rules section of this issue of the
Section 218(a) of the Nuclear Waste Policy Act (NWPA) of 1982, as amended, requires that “the Secretary [of the Department of Energy] shall establish a demonstration program, in cooperation with the private sector, for the dry storage of spent nuclear fuel at civilian nuclear power reactor sites, with the objective of establishing one or more technologies that the [U.S. Nuclear Regulatory] Commission may, by rule, approve for use at the sites of civilian nuclear power reactors without, to the maximum extent practicable, the need for additional site-specific approvals by the Commission.” Section 133 of the NWPA states, in part, that “[the Commission] shall, by rule, establish procedures for the licensing of any technology approved by the Commission under Section 219(a) [sic: 218(a)] for use at the site of any civilian nuclear power reactor.”
To implement this mandate, the Commission approved dry storage of spent nuclear fuel in NRC-approved casks under a general license by publishing a final rule that added a new subpart K in part 72 of title 10 of the
On May 23, 2017, NAC International submitted a request to the NRC to amend CoC No. 1015. NAC International supplemented its request on January 16, 2018. Amendment No. 6 revises the CoC's TSs to: (1) Remove a redundant requirement for inspection of the concrete cask and canister; (2) revise an LCO for heat removal to clarify that “LCO not met” means that the concrete heat removal system is inoperable; (3) remove an inspection requirement that is already covered by LCO surveillance requirements for off-normal, accident, or natural phenomenon events; (4) clarify that “immediate” restoration of a concrete cask's heat removal capabilities means “within the design-basis time limit” in Section 11.2.13 of the FSAR, “or within the time limit for a less than design-basis heat load case, as evaluated”; and (5) clarify that an LCO for loaded cask surface dose rates applies prior to storage conditions, when dose rates will be highest.
As documented in the preliminary safety evaluation report (PSER), the NRC performed a safety review of the proposed CoC amendment request. There are no significant changes to cask design requirements in the proposed CoC amendment. Considering the specific design requirements for each accident condition, the design of the cask would prevent loss of containment, shielding, and criticality control in the event of an accident. This amendment does not reflect a significant change in design or fabrication of the cask. In addition, any resulting occupational exposure or offsite dose rates from the implementation of Amendment No. 6 would remain well within the 10 CFR part 20 limits. There will be no significant change in the types or amounts of any effluent released, no significant increase in the individual or cumulative radiation exposure, and no significant increase in the potential for, or consequences from, radiological accidents.
This direct final rule revises the NAC-UMS® System listing in § 72.214 by adding Amendment No. 6 to CoC No. 1015. The amendment consists of the changes previously described, as set forth in the revised CoC and TSs. The revised TSs are identified and evaluated in the PSER.
The amended NAC-UMS® cask design, when used under the conditions specified in the CoC, the TSs, and the NRC's regulations, will meet the requirements of 10 CFR part 72; therefore, adequate protection of public health and safety will continue to be ensured. When this direct final rule becomes effective, persons who hold a general license under § 72.210 may, consistent with the license conditions under § 72.212, load spent nuclear fuel into those NAC-UMS® Universal Storage System casks that meet the
The National Technology Transfer and Advancement Act of 1995 (Pub. L. 104-113) requires that Federal agencies use technical standards that are developed or adopted by voluntary consensus standards bodies unless the use of such a standard is inconsistent with applicable law or otherwise impractical. In this direct final rule, the NRC will revise the NAC-UMS® Universal Storage System design listed in § 72.214. This action does not constitute the establishment of a standard that contains generally applicable requirements.
Under the “Policy Statement on Adequacy and Compatibility of Agreement State Programs” approved by the Commission on June 30, 1997, and published in the
The Plain Writing Act of 2010 (Pub. L. 111-274) requires Federal agencies to write documents in a clear, concise, and well-organized manner. The NRC has written this document to be consistent with the Plain Writing Act as well as the Presidential Memorandum, “Plain Language in Government Writing,” published June 10, 1998 (63 FR 31883).
The action is to amend § 72.214 to revise the NAC International NAC-UMS® Universal Storage System listing of casks that power reactor licensees can use for dry storage of spent fuel at reactor sites under a general license. This direct final rule amends the listing to add Amendment No. 6 to CoC No. 1015. Specifically, Amendment No. 6 revises the CoC's TSs to: (1) Remove a redundant requirement for inspection of the concrete cask and canister; (2) revise an LCO for heat removal to clarify that “LCO not met” means that the concrete heat removal system is inoperable; (3) remove an inspection requirement that is already covered by LCO surveillance requirements for off-normal, accident, or natural phenomenon events; (4) clarify that “immediate” restoration of a concrete cask's heat removal capabilities means “within the design-basis time limit” in Section 11.2.13 of the FSAR, “or within the time limit for a less than design-basis heat load case, as evaluated”; and (5) clarify that an LCO for loaded cask surface dose rates applies prior to storage conditions, when dose rates will be highest.
This direct final rule amends the CoC for the NAC-UMS® Universal Storage System design within the list of approved spent fuel storage casks that power reactor licensees can use to store spent fuel at reactor sites under a general license. Specifically, Amendment No. 6 clarifies and removes redundancies in requirements for the use of the NAC-UMS® Universal Storage System. The amendment facilitates the dry cask storage of spent fuel that might otherwise have to be stored in the affected power reactors' spent fuel storage pools.
On July 18, 1990 (55 FR 29181), the NRC issued an amendment to 10 CFR part 72 to provide for the storage of spent fuel under a general license in cask designs approved by the NRC. The potential environmental impact of using NRC-approved storage casks was initially analyzed in the environmental assessment (EA) for the 1990 final rule. The EA for this Amendment No. 6 tiers off of the EA for the July 18, 1990, final rule. Tiering off past EAs is a standard process under the National Environmental Policy Act of 1969, as amended (NEPA).
NAC-UMS® Universal Storage Systems are designed to mitigate the effects of design basis accidents that could occur during storage. Design basis accidents account for human-induced events and the most severe natural phenomena reported for the site and surrounding area. Postulated accidents analyzed for an independent spent fuel storage installation, the type of facility at which a holder of a power reactor operating license would store spent fuel in casks in accordance with 10 CFR part 72, include tornado winds and tornado-generated missiles, a design basis earthquake, a design basis flood, an accidental cask drop, lightning effects, fire, explosions, and other events.
Considering the specific design requirements for each accident condition, the design of the cask would prevent loss of confinement, shielding, and criticality control in the event of an accident. If there is no loss of confinement, shielding, or criticality control, the environmental impacts resulting from an accident would be insignificant. This amendment does not reflect a significant change in design or fabrication of the cask. Because there are no significant design or process changes, any resulting occupational exposure or offsite dose rates from the implementation of Amendment No. 6 would remain well within 10 CFR part 20 limits. Therefore, the proposed CoC changes will not result in any radiological or non-radiological environmental impacts that significantly differ from the environmental impacts evaluated in the EA supporting the July 18, 1990, final rule. There will be no significant change in the types or amounts of any effluent released, no significant increase in individual or cumulative radiation exposures, and no significant increase in the potential for or consequences of radiological accidents. The NRC documented its safety findings in a PSER.
The alternative to this action is to deny approval of Amendment No. 6 and end the direct final rule. Consequently, any 10 CFR part 72 general licensee that seeks to load spent nuclear fuel into NAC International NAC-UMS® Universal Storage Systems in accordance with the changes described in proposed Amendment No. 6 would have to request an exemption from the requirements of §§ 72.212 and 72.214. Under this alternative, interested licensees would have to prepare, and the NRC would have to review, a separate exemption request, thereby increasing the administrative burden upon the NRC and the costs to each licensee. Therefore, the environmental impacts of the alternative action would be the same as, or more likely greater than, the preferred action.
Approval of Amendment No. 6 to CoC No. 1015 would result in no irreversible commitment of resources.
No agencies or persons outside the NRC were contacted in connection with the preparation of this EA.
The environmental impacts of the action have been reviewed under the requirements in NEPA, and the NRC's regulations in subpart A of 10 CFR part 51, “Environmental Protection Regulations for Domestic Licensing and Related Regulatory Functions.” Based on the foregoing EA, the NRC concludes that this direct final rule entitled, “List of Approved Spent Fuel Storage Casks: NAC International NAC-UMS® Universal Storage System, Certificate of Compliance No. 1015, Amendment No. 6” will not have a significant effect on the human environment. Therefore, the NRC has determined that an environmental impact statement is not necessary for this direct final rule.
This direct final rule does not contain any new or amended collections of information subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
The NRC may not conduct or sponsor, and a person is not required to respond to a request for information or an information collection requirement unless the requesting document displays a currently valid OMB control number.
Under the Regulatory Flexibility Act of 1980 (5 U.S.C. 605(b)), the NRC certifies that this direct final rule will not, if issued, have a significant economic impact on a substantial number of small entities. This direct final rule affects only nuclear power plant licensees and NAC International. These entities do not fall within the scope of the definition of small entities set forth in the Regulatory Flexibility Act or the size standards established by the NRC (§ 2.810).
On July 18, 1990 (55 FR 29181), the NRC issued an amendment to 10 CFR part 72 to provide for the storage of spent nuclear fuel under a general license in cask designs approved by the NRC. Any nuclear power reactor licensee can use NRC-approved cask designs to store spent nuclear fuel if it notifies the NRC in advance, the spent fuel is stored under the conditions specified in the cask's CoC, and the conditions of the general license are met. A list of NRC-approved cask designs is contained in § 72.214. On October 19, 2000 (65 FR 62581), the NRC issued an amendment to 10 CFR part 72 that approved the NAC-UMS® Universal Storage System design by adding it to the list of NRC-approved cask designs in § 72.214.
On May 23, 2017, and as supplemented on January 16, 2018, NAC International submitted an application to amend the NAC-UMS® Universal Storage System as described in Section IV, “Discussion of Changes,” of this document.
The alternative to this action is to withhold approval of Amendment No. 6 and to require any 10 CFR part 72 general licensee seeking to load spent nuclear fuel into NAC International NAC-UMS® Universal Storage Systems under the changes described in Amendment No. 6 to request an exemption from the requirements of §§ 72.212 and 72.214. Under this alternative, each interested 10 CFR part 72 licensee would have to prepare, and the NRC would have to review, a separate exemption request, thereby increasing the administrative burden upon the NRC and the costs to each licensee.
Approval of this direct final rule is consistent with previous NRC actions. Further, as documented in the PSER and EA, this direct final rule will have no adverse effect on public health and safety or the environment. This direct final rule has no significant identifiable impact or benefit on other Government agencies. Based on this regulatory analysis, the NRC concludes that the requirements of this direct final rule are commensurate with the NRC's responsibilities for public health and safety and the common defense and security. No other available alternative is believed to be as satisfactory, and therefore, this action is recommended.
The NRC has determined that the actions in this direct final rule do not require a backfit analysis because they either do not fall within the definition of backfitting under § 72.62 or § 50.109(a)(1), or they do not impact any general licensees currently using these systems. Additionally, the actions in this direct final rule do not impact issue finality provisions applicable to combined licenses under 10 CFR part 52.
This direct final rule revises CoC No. 1015 for the NAC International NAC-UMS® Universal Storage System, as currently listed in § 72.214. The revision consists of Amendment No. 6, which revises the CoC's TSs to: (1) Remove a redundant requirement for inspection of the concrete cask and canister; (2) revise an LCO for heat removal to clarify that “LCO not met” means that the concrete heat removal system is inoperable; (3) remove an inspection requirement that is already covered by LCO surveillance requirements for off-normal, accident, or natural phenomenon events; (4) clarify that “immediate” restoration of a concrete cask's heat removal capabilities means “within the design-basis time limit” in Section 11.2.13 of the FSAR, “or within the time limit for a less than design-basis heat load case, as evaluated”; and (5) clarify that an LCO for loaded cask surface dose rates applies prior to storage conditions, when dose rates will be highest.
Amendment No. 6 to CoC No. 1015 for the NAC International NAC-UMS® Universal Storage System was initiated by NAC International and was not submitted in response to new NRC requirements, or an NRC request for amendment. Amendment No. 6 applies only to new casks fabricated and used under Amendment No. 6. These changes do not affect existing users of the NAC International NAC-UMS® Universal Storage System, and the current Amendment No. 5 continues to be effective for existing users. While current CoC users may comply with the new requirements in Amendment No. 6, this would be a voluntary decision on the part of current users.
For these reasons, Amendment No. 6 to CoC No. 1015 does not constitute backfitting under § 72.62 or § 50.109(a)(1), or otherwise represent an inconsistency with the issue finality provisions applicable to combined licenses in 10 CFR part 52. Accordingly, the NRC has not prepared a backfit analysis for this rulemaking.
This direct final rule is not a rule as defined in the Congressional Review Act.
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
Administrative practice and procedure, Hazardous waste, Indians, Intergovernmental relations, Nuclear energy, Penalties, Radiation protection, Reporting and recordkeeping requirements, Security measures, Whistleblowing.
For the reasons set out in the preamble and under the authority of the Atomic Energy Act of 1954, as amended; the Energy Reorganization Act of 1974, as amended; the Nuclear Waste Policy Act of 1982, as amended; and 5 U.S.C. 552 and 553; the NRC is adopting the following amendments to 10 CFR part 72:
Atomic Energy Act of 1954, secs. 51, 53, 57, 62, 63, 65, 69, 81, 161, 182, 183, 184, 186, 187, 189, 223, 234, 274 (42 U.S.C. 2071, 2073, 2077, 2092, 2093, 2095, 2099, 2111, 2201, 2210e, 2232, 2233, 2234, 2236, 2237, 2238, 2273, 2282, 2021); Energy Reorganization Act of 1974, secs. 201, 202, 206, 211 (42 U.S.C. 5841, 5842, 5846, 5851); National Environmental Policy Act of 1969 (42 U.S.C. 4332); Nuclear Waste Policy Act of 1982, secs. 117(a), 132, 133, 134, 135, 137, 141, 145(g), 148, 218(a) (42 U.S.C. 10137(a), 10152, 10153, 10154, 10155, 10157, 10161, 10165(g), 10168, 10198(a)); 44 U.S.C. 3504 note.
For the Nuclear Regulatory Commission.
Federal Aviation Administration (FAA), DOT.
Amended final special conditions; request for comments.
These amended special conditions are issued for the Boeing Model 777 series airplanes. These special conditions are for oblique (side-facing) seats, installed in Boeing Model 777 series airplanes, at an angle of 18 to 45 degrees to the airplane centerline and which may include a 3-point or airbag restraint system, or both, for occupant restraint and injury protection. This amendment adds a note and one special condition to the Special Conditions section. This airplane will have novel or unusual design features when compared to the state of technology envisioned in the airworthiness standards for transport category airplanes. These design features are oblique (side-facing) single-occupant passenger seats equipped with or without airbag devices or 3-point restraints. The applicable airworthiness regulations do not contain adequate or appropriate safety standards for this design feature. These special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.
This action is effective on The Boeing Company on October 22, 2018. Send comments on or before December 6, 2018.
Send comments identified by Docket No. FAA-2016-4136 using any of the following methods:
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John Shelden, Airframe and Cabin Safety Section, AIR-675, Transport Standards Branch, Policy and Innovation Division, Aircraft Certification Service, Federal Aviation Administration, 2200 South 216th Street, Des Moines, Washington 98198; telephone and fax 206-231-3214; email
The substance of these special conditions has been published in the
We invite interested people to take part in this rulemaking by sending written comments, data, or views. The most helpful comments reference a specific portion of the special conditions, explain the reason for any recommended change, and include supporting data.
We will consider all comments we receive by the closing date for comments. We may change these special conditions based on the comments we receive.
On November 22, 2017, Boeing applied for an amendment to Type Certificate No. T00001SE for the installation of oblique (side-facing) passenger seats with or without airbag devices or 3-point restraints in the Boeing Model 777 series airplanes. The Boeing Model 777 series airplanes are twin-engine, transport category airplanes with a maximum certified passenger capacity of up to 550 and a maximum takeoff weight of approximately 775,000 lbs.
Under the provisions of title 14, Code of Federal Regulations (14 CFR) 21.101, Boeing must show that the Model 777 series airplanes meet the applicable provisions of the regulations listed in Type Certificate No. T00001SE, or the applicable regulations in effect on the date of application for the change, except for earlier amendments as agreed upon by the FAA.
If the Administrator finds that the applicable airworthiness regulations (
Special conditions are initially applicable to the model for which they are issued. Should the type certificate for that model be amended later to include any other model that incorporates the same novel or unusual design feature, or should any other model already included on the same type certificate be modified to incorporate the same novel or unusual design feature, these special conditions would also apply to the other model under § 21.101.
In addition to the applicable airworthiness regulations and special conditions, the Boeing Model 777 series airplanes must comply with the fuel vent and exhaust emission requirements of 14 CFR part 34 and the noise certification requirements of 14 CFR part 36.
The FAA issues special conditions, as defined in 14 CFR 11.19, in accordance with § 11.38, and they become part of the type certification basis under § 21.101.
The business-class seating configuration Boeing proposes is novel or unusual due to the seat installation at 30 degrees to the airplane centerline, the airbag-system installation, and the seat/occupant interface with the surrounding furniture that introduces occupant alignment and loading concerns. The proposed business-class seating configuration is also beyond the limits of current acceptable equivalent-level-of-safety findings. These oblique (side-facing) seats may be installed at an angle of 18 to 45 degrees to the airplane centerline and may include a 3-point or airbag restraint system, or both, for occupant restraint and injury protection.
The existing regulations do not provide adequate or appropriate safety standards for occupants of oblique-angled seats with airbag systems. To provide a level of safety that is equivalent to that afforded occupants of forward- and aft-facing seats, additional airworthiness standards, in the form of special conditions, are necessary. These special conditions supplement part 25 and, more specifically, supplement §§ 25.562 and 25.785.
The requirements contained in these special conditions consist of both test conditions and injury pass/fail criteria.
The FAA has been conducting and sponsoring research on appropriate injury criteria for oblique (side-facing) seat installations. However, the FAA research program is not complete and we may update these criteria as we obtain further research results. To reflect current research findings, the FAA issued policy statement PS-ANM-25-03-R1 to update injury criteria for fully side-facing seats, and policy statement PS-AIR-25-27, to define injury criteria for oblique (side-facing) seats.
The proposed Boeing Model 777 series airplanes business-class seat installation is novel such that the current Boeing Model 777 series airplanes certification basis does not adequately address protection of the occupant's neck and spine for seat configurations that are positioned at an angle greater than 18 degrees from the airplane centerline. The FAA issued special conditions No. 25-569-SC for
The installation of passenger seats at angles of 18 to 45 degrees to the airplane centerline are unique due to the seat/occupant interface with the surrounding furniture that introduces occupant alignment/loading concerns with or without the installation of a 3-point or airbag restraint system, or both. On-going research has invalidated previously released special conditions for oblique (side-facing) seat installations. These updated special conditions further address potential injuries to the occupant's neck and spine. As a result, these special conditions replace special conditions 25-569-SC and 25-621-SC. This amendment adds a note to special condition number 7 and adds special condition number 8 to the Special Condition section. The note and special condition 8 were unintentionally omitted from the previous issuance of these special conditions. This additional text is standard, in all material respects, in previously issued special conditions of the same topic.
FAA-sponsored research has found that an un-restrained flailing of the upper torso, even when the pelvis and torso are nearly aligned, can produce serious spinal and torso injuries. At lower impact severities, even with significant misalignment between the torso and pelvis, these injuries did not occur. Tests with an FAA H-III anthropomorphic test device (ATD) have identified a level of lumbar spinal tension corresponding to the no-injury impact severity. This level of tension is included as a limit in the special conditions. The spine tension limit selected is conservative with respect to other aviation injury criteria since it corresponds to a no-injury loading condition.
As noted in the special conditions for each airbag restraint system, because an airbag restraint system is essentially a single use device, there is the potential that it could deploy under crash conditions that are not sufficiently severe as to require head injury protection from the airbag restraint system. Since an actual crash is frequently composed of a series of impacts before the airplane comes to rest, this could render the airbag restraint system useless if a larger impact follows the initial impact. This situation does not exist with energy absorbing pads or upper torso restraints, which tend to provide protection according to the severity of the impact. Therefore, the installation of the airbag restraint system should be such that the airbag restraint system will provide protection when it is required, and will not expend its protection when it is not needed.
Because these airbag restraint systems may or may not activate during various crash conditions, the injury criteria listed in these special conditions and in § 25.562 must be met in an event that is slightly below the activation level of the airbag restraint system. If an airbag restraint system is included with the oblique seats, the system must meet the requirements in one of the airbag (inflatable restraint) special conditions applicable to the Boeing Model 777 series airplanes.
These amended special conditions will provide head injury criteria, neck injury criteria, spine injury criteria, and body-to-wall contact criteria. They contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.
As discussed above, these special conditions are applicable to the Boeing Model 777 series airplane. Should Boeing apply at a later date for a change to the type certificate to include another model incorporating the same novel or unusual design feature, these special conditions would apply to that model as well.
This action affects only certain novel or unusual design features on one model series of airplanes. It is not a rule of general applicability.
Aircraft, Aviation safety, Reporting and recordkeeping requirements.
The authority citation for these special conditions is as follows:
49 U.S.C. 106(f), 106(g), 40113, 44701, 44702, 44704.
Accordingly, pursuant to the authority delegated to me by the Administrator, the following special conditions are issued as part of the type certification basis for the Boeing Model 777 series airplanes.
In addition to the requirements of § 25.562:
Compliance with § 25.562(c)(5) is required, except that, if the ATD has no apparent contact with the seat/structure but has contact with an airbag, a HIC unlimited score in excess of 1000 is acceptable, provided the HIC15 score for that contact (calculated in accordance with 49 CFR 571.208) is less than 700.
If a seat is installed aft of structure (
The seating system must protect the occupant from experiencing serious neck injury. The assessment of neck injury must be conducted with the airbag device activated, unless there is a reason to also consider that the neck-injury potential would be higher for impacts below the airbag-device deployment threshold.
a. The N
b. In addition, peak upper-neck F
c. Rotation of the head about its vertical axis, relative to the torso is limited to 105 degrees in either direction from forward-facing.
d. The neck must not impact any surface that would produce concentrated loading on the neck.
a. The lumbar spine tension (F
b. Significant concentrated loading on the occupant's spine, in the area
c. The occupant must not interact with the armrest or other seat components in any manner significantly different than would be expected for a forward-facing seat installation.
Any part of the load-bearing portion of the bottom of the ATD pelvis must not translate beyond the edges of the seat bottom seat-cushion supporting structure.
Axial rotation of the upper leg (about the z-axis of the femur per SAE Recommended Practice J211/1) must be limited to 35 degrees from the nominal seated position. Evaluation during rebound does not need to be considered.
Longitudinal tests conducted to measure the injury criteria above must be performed with the FAA Hybrid III ATD, as described in SAE 1999-01-1609, “A Lumbar Spine Modification to the Hybrid III ATD for Aircraft Seat Tests.” The tests must be conducted with an undeformed floor, at the most-critical yaw cases for injury, and with all lateral structural supports (
Boeing must demonstrate that the installation of seats via plinths or pallets meets all applicable requirements. Compliance with the guidance contained in policy memorandum PS-ANM-100-2000-00123, “Guidance for Demonstrating Compliance with Seat Dynamic Testing for Plinths and Pallets,” dated February 2, 2000, is acceptable to the FAA.
If inflatable airbag restraint systems are installed, the airbag systems must meet the requirements in one of the airbag (inflatable restraint) special conditions applicable to the Boeing Model 777 series airplanes.
Federal Aviation Administration (FAA), DOT.
Final special conditions; request for comments.
These special conditions are issued for the Mitsubishi Aircraft Corporation Model MRJ-200 airplane. This airplane will have novel or unusual design features when compared to the state of technology envisioned in the airworthiness standards for transport category airplanes. These design features include passenger seats that incorporate non-traditional, large, non-metallic panels in lieu of the traditional metal frame covered by fabric. The applicable airworthiness regulations do not contain adequate or appropriate safety standards for this design feature. These special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.
This action is effective on Mitsubishi Aircraft Corporation on October 22, 2018. Send comments on or before December 6, 2018.
Send comments identified by Docket No. FAA-2018-0932 using any of the following methods:
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Nicholas Wilson, International Section, AIR-676, Transport Standards Branch, Policy and Innovation Division, Aircraft Certification Service, Federal Aviation Administration, 2200 South 216th Street, Des Moines, Washington 98198; telephone and fax 206-231-3230; email
The substance of these special conditions has been published in the
We invite interested people to take part in this rulemaking by sending written comments, data, or views. The most helpful comments reference a specific portion of the special conditions, explain the reason for any recommended change, and include supporting data.
We will consider all comments we receive by the closing date for comments. We may change these special conditions based on the comments we receive.
On August 19, 2009, Mitsubishi Aircraft Corporation applied for a type certificate for their new Model MRJ-200 airplane. The Mitsubishi Aircraft Corporation Model MRJ-200 airplane is a low-wing, conventional-tail design with two wing-mounted turbofan engines. The primary structure is metal with an aluminum wing and composite empennage. The airplane is equipped with an electronic flight control system. The airplane has seating for 96 passengers and a maximum takeoff weight of 98,800 lbs.
Under the provisions of title 14, Code of Federal Regulations (14 CFR) 21.17, Mitsubishi Aircraft Corporation must show that the Model MRJ-200 airplane meets the applicable provisions of part 25, as amended by amendments 25-1 through 25-141; part 36, as amended by amendments 36-1 through 36-30; and part 34, as amended by amendments 34-1 through the amendment effective at the time of design approval.
If the Administrator finds that the applicable airworthiness regulations (
Special conditions are initially applicable to the model for which they are issued. Should the type certificate for that model be amended later to include any other model that incorporates the same novel or unusual design feature, these special conditions would also apply to the other model under § 21.101.
In addition to the applicable airworthiness regulations and special conditions, the Mitsubishi Aircraft Corporation Model MRJ-200 airplane must comply with the fuel vent and exhaust emission requirements of 14 CFR part 34 and the noise certification requirements of 14 CFR part 36.
The FAA issues special conditions, as defined in 14 CFR 11.19, in accordance with § 11.38, and they become part of the type certification basis under § 21.17(a)(2).
The Mitsubishi Aircraft Corporation Model MRJ-200 airplane will incorporate the following novel or unusual design features:
Passenger seats that incorporate non-traditional, large, non-metallic panels in lieu of the traditional metal frame covered by fabric.
A non-traditional, large, non-metallic panel, in this case, is defined as a panel with exposed surface areas greater than 1.5 square feet installed per seat place. The panel may consist of either a single component or multiple components in a concentrated area. Examples of parts of the seat where these non-traditional panels are installed include, but are not limited to: seat backs, bottoms and leg/foot rests, kick panels, back shells, credenzas and associated furniture. Examples of traditional exempted parts of the seat include: arm caps, armrest close-outs such as end bays and armrest-styled center consoles, food trays, video monitors and shrouds.
“Exposed” includes those panels directly exposed to the passenger cabin in the traditional sense, plus those panels enveloped such as by a dress cover. Traditional fabrics or leathers currently used on seats are excluded from these special conditions. These materials must still comply with 14 CFR 25.853(a) and (c) if used as a covering for a seat cushion, or 14 CFR 25.853(a) if installed elsewhere on the seat. Non-traditional, large, non-metallic panels covered with traditional fabrics or leathers will be tested without their coverings or covering attachments.
In the early 1980s, the FAA conducted extensive research on the effects of post-crash flammability in the passenger cabin. As a result of this research and service experience, the FAA adopted new standards for interior surfaces associated with large surface area parts. Specifically, the rules require measurement of heat release and smoke emission (part 25, appendix F, parts IV and V) for the affected parts. Heat release has been shown to have a direct correlation with post-crash fire survival time. Materials that comply with the standards (
At the time these standards were written, the potential application of the requirements of heat release and smoke emission to seats was explored. The seat frame itself was not a concern because it was primarily made of aluminum and there were only small amounts of non-metallic materials. It was determined that the overall effect on survivability was negligible, whether or not the food trays met the heat release and smoke requirements. The requirements, therefore, did not address seats. The preambles to both the Notice of Proposed Rulemaking, Notice No. 85-10, 50 FR 15038, April 16, 1985, and the Final Rule, amendment 25-61, 51 FR 26206, July 21, 1986, specifically note that seats were excluded because the recently-adopted standards for flammability of seat cushions will greatly inhibit involvement of the seats.
Subsequently, the Final Rule, amendment 25-83, 60 FR 6615, March 6, 1995, clarified the definition of minimum panel size by stating that it is not possible to cite a specific size that will apply in all installations; however, as a general rule, components with exposed surface areas of one square foot or less may be considered small enough that they do not have to meet the new standards. Components with exposed surface areas greater than two square feet may be considered large enough that they do have to meet the new standards. Those with exposed surface areas greater than one square foot, but less than two square feet, must be considered in conjunction with the areas of the cabin in which they are installed before a determination could be made.
The FAA issued Policy Statement PS-ANM100-97-112-39, Guidance for Flammability Testing of Seat/Console Installations, on October 17, 1997 (
In October of 2004, an issue was raised regarding the appropriate flammability standards for passenger seats that incorporated non-traditional, large, non-metallic panels in lieu of the traditional metal covered by fabric. The FAA determined that special conditions would be promulgated to apply the standards defined in 14 CFR 25.853(d) to seats with large, non-metallic panels in their design.
These special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to
As discussed above, these special conditions are applicable to the Mitsubishi Aircraft Corporation Model MRJ-200 airplane. Should Mitsubishi Aircraft Corporation apply at a later date for a change to the type certificate to include another model incorporating the same novel or unusual design feature, these special conditions would apply to that model as well.
This action affects only a certain novel or unusual design feature on one model of airplane. It is not a rule of general applicability.
Aircraft, Aviation safety, Reporting and recordkeeping requirements.
The authority citation for these special conditions is as follows:
49 U.S.C. 106(f), 106(g), 40113, 44701, 44702, 44704.
Accordingly, pursuant to the authority delegated to me by the Administrator, the following special conditions are issued as part of the type certification basis for Mitsubishi Aircraft Company Model MRJ-200 airplanes.
1. Except as provided in paragraph 3 of these special conditions, compliance with 14 CFR part 25, appendix F, part IV, Heat Release and part V, Smoke Emission, is required for seats that incorporate non-traditional, large, non-metallic panels that may either be a single component or multiple components in a concentrated area in their design.
2. The applicant may designate up to and including 0.139 square meter (1.5 square feet of non-traditional, non-metallic panel material per seat place that does not have to comply with paragraph 1 of these special conditions. A double seat assembly may have a total of 0.278 square meter (3.0 square feet) excluded on any portion of the assembly (
3. Seats do not have to meet the test requirements of 14 CFR part 25, appendix F, parts IV and V, when installed in compartments defined in 14 CFR 25.853(e).
Federal Aviation Administration (FAA), DOT.
Final special conditions; request for comments.
These special conditions are issued for the Bombardier, Inc., (Bombardier) BD-700-2A12 and BD-700-2A13 airplanes, marketed respectively as Global 7000 and Global 8000. These airplanes, as modified by Bombardier, will have novel or unusual design features when compared to the state of technology envisioned in the airworthiness standards for transport-category airplanes. These design features are multiple-place side-facing seats with active leg-flail restraint devices and shoulder-belt airbags. The applicable airworthiness regulations do not contain adequate or appropriate safety standards for this design feature. These special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.
This action is effective on Bombardier on October 22, 2018. Send comments on or before December 6, 2018.
Send comments identified by Docket No. FAA-2018-0714 using any of the following methods:
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Alan Sinclair, Airframe and Cabin Safety Section, AIR-675, Transport Standards Branch, Policy and Innovation Division, Aircraft Certification Service, Federal Aviation Administration, 2200 South 216th Street, Des Moines, Washington 98198; telephone and fax 206-231-3215; email
The substance of these special conditions has been published in the
We invite interested people to take part in this rulemaking by sending written comments, data, or views. The most helpful comments reference a specific portion of the special conditions, explain the reason for any recommended change, and include supporting data.
We will consider all comments we receive by the closing date for comments. We may change these special
On June 10, 2015, Bombardier applied for a supplemental type certificate for multiple-place side-facing seats equipped with active leg-flail restraint devices and shoulder-belt airbags in the Model BD-700-2A12 and BD-700-2A13 airplanes.
These airplanes are derivatives of the Model BD-700 series of airplanes and are marketed as the Bombardier Global 7000 (Model BD-700-2A12) and Global 8000 (Model BD-700-2A13). These airplanes are twin-engine, transport-category, executive-interior business jets. The maximum passenger capacity is 19 and the maximum takeoff weights are 106,250 lb. (Model BD-700-2A12) and 104,800 lb. (Model BD-700-2A13).
Under the provisions of title 14, Code of Federal Regulations (14 CFR) 21.101, Bombardier must show that the Model BD-700-2A12 and BD-700-2A13 airplanes, as changed, continue to meet the applicable provisions of the regulations listed in type certificate no. T00003NY or the applicable regulations in effect on the date of application for the change, except for earlier amendments as agreed upon by the FAA.
If the Administrator finds that the applicable airworthiness regulations (
Special conditions are initially applicable to the model for which they are issued. Should the applicant apply for a supplemental type certificate to modify any other model included on the same type certificate to incorporate the same novel or unusual design feature, these special conditions would also apply to the other model under § 21.101.
In addition to the applicable airworthiness regulations and special conditions, the Bombardier Model BD-700-2A12 and BD-700-2A13 airplanes must comply with the fuel-vent and exhaust-emission requirements of 14 CFR part 34, and the noise certification requirements of 14 CFR part 36.
The FAA issues special conditions, as defined in 14 CFR 11.19, in accordance with § 11.38, and they become part of the type certification basis under § 21.101.
The Bombardier Model BD-700-2A12 and BD-700-2A13 airplanes will incorporate the following novel or unusual design features:
Multiple-place side-facing seats with active leg-flail restraint devices and shoulder-belt airbags.
Many proposed airplane interior configurations include multiple-place side-facing seats and single-place side-facing seats (hereafter referred to as side-facing seats). Some of these side-facing seat designs include an airbag system in the shoulder belt, and some may also include leg-flail protection. The FAA has determined that the existing regulations do not provide adequate or appropriate safety standards for occupants of side facing seats. In addition, the FAA has determined that the existing regulations do not provide adequate or appropriate safety standards for the addition of airbag systems in the shoulder belt on side-facing seats.
Side-facing seats are considered a novel design for transport-category airplanes that include § 25.562 in their certification basis. The performance measures of § 25.562(c) only address forward- and aft-facing seats, and do not provide adequate or appropriate safety standards for occupants of side-facing seats because they do not consider the differences in the dynamic forces that apply to a side-facing occupant.
The FAA issued Policy Statement PS-ANM-25-03-R1 to provide technical criteria for approving side-facing seats, to be issued as special conditions for the design approval of such seats. The technical criteria set forth in that policy are the result of FAA research findings and provide the level of safety envisioned in § 25.562. These technical criteria are applicable to all fully side-facing seats, both multiple-place and single-place.
These special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.
As discussed above, these special conditions are applicable to the Bombardier BD-700-2A12 and BD-700-2A13 airplanes. Should Bombardier apply at a later date for a change to the type certificate to include another model incorporating the same novel or unusual design feature, these special conditions would apply to that model as well.
This action affects only certain novel or unusual design features on the Bombardier BD-700-2A12 and BD-700-2A13 airplanes. It is not a rule of general applicability.
Aircraft, Aviation safety, Reporting and recordkeeping requirements.
The authority citation for these special conditions is as follows:
49 U.S.C. 106(f), 106(g), 40113, 44701, 44702, 44704.
Accordingly, pursuant to the authority delegated to me by the Administrator, the following special conditions are issued as part of the type certification basis for Bombardier BD-700-2A12 and BD-700-2A13 airplanes as modified by Bombardier.
1. Additional requirements applicable to tests or rational analysis conducted to show compliance with §§ 25.562 and 25.785 for side-facing seats:
a. The longitudinal test(s) conducted in accordance with § 25.562(b)(2) to show compliance with the seat-strength requirements of § 25.562(c)(7) and (8), and these special conditions must have an ES-2re anthropomorphic test dummy (ATD) (49 CFR part 572, subpart U) or equivalent, or a Hybrid-II ATD (49 CFR part 572, subpart B, as specified in § 25.562) or equivalent, occupying each seat position and including all items contactable by the occupant (
b. The longitudinal test(s) conducted in accordance with § 25.562(b)(2), to show compliance with the injury assessments required by § 25.562(c) and these special conditions, may be conducted separately from the test(s) to show structural integrity. In this case, structural-assessment tests must be conducted as specified in paragraph 1a, above, and the injury-assessment test must be conducted without yaw or floor misalignment. Injury assessments may be accomplished by testing with ES-2re ATD (49 CFR part 572, subpart U) or equivalent at all places. Alternatively, these assessments may be accomplished by multiple tests that use an ES-2re at the seat place being evaluated, and a Hybrid-II ATD (49 CFR part 572, subpart B, as specified in § 25.562) or equivalent used in all seat places forward of the one being assessed, to evaluate occupant interaction. In this case, seat places aft of the one being assessed may be unoccupied. If a seat installation includes adjacent items that are contactable by the occupant, the injury potential of that contact must be assessed. To make this assessment, tests may be conducted that include the actual item, located and attached in a representative fashion. Alternatively, the injury potential may be assessed by a combination of tests with items having the same geometry as the actual item, but having stiffness characteristics that would create the worst case for injury (injuries due to both contact with the item and lack of support from the item).
c. If a seat is installed aft of structure (
d. To accommodate a range of occupant heights (5th percentile female to 95th percentile male), the surface of items contactable by the occupant must be homogenous 7.3 inches (185 mm) above and 7.9 inches (200 mm) below the point (center of area) that is contacted by the 50th percentile male size ATD's head during the longitudinal test(s) conducted in accordance with paragraphs a, b, and c, above. Otherwise, additional head-injury criteria (HIC) assessment tests may be necessary. Any surface (inflatable or otherwise) that provides support for the occupant of any seat place must provide that support in a consistent manner regardless of occupant stature. For example, if an inflatable shoulder belt is used to mitigate injury risk, then it must be demonstrated by inspection to bear against the range of occupants in a similar manner before and after inflation. Likewise, the means of limiting lower-leg flail must be demonstrated by inspection to provide protection for the range of occupants in a similar manner.
e. For longitudinal test(s) conducted in accordance with § 25.562(b)(2) and these special conditions, the ATDs must be positioned, clothed, and have lateral instrumentation configured as follows:
f. ATD positioning:
i. Lower the ATD vertically into the seat while simultaneously:
ii. Aligning the midsagittal plane (a vertical plane through the midline of the body; dividing the body into right and left halves) with approximately the middle of the seat place.
iii. Applying a horizontal x-axis direction (in the ATD coordinate system) force of about 20 lb (89 N) to the torso at approximately the intersection of the midsagittal plane and the bottom rib of the ES-2re or lower sternum of the Hybrid-II at the midsagittal plane, to compress the seat back cushion.
iv. Keeping the upper legs nearly horizontal by supporting them just behind the knees. Once all lifting devices have been removed from the ATD:
1. Rock it slightly to settle it in the seat.
2. Separate the knees by about 4 inches (100 mm).
3. Set the ES-2re's head at approximately the midpoint of the available range of z-axis rotation (to align the head and torso midsagittal planes).
4. Position the ES-2re's arms at the joint's mechanical detent that puts them at approximately a 40 degree angle with respect to the torso. Position the Hybrid-II ATD hands on top of its upper legs.
5. Position the feet such that the centerlines of the lower legs are approximately parallel to a lateral vertical plane (in the aircraft coordinate system).
g.
h.
2. The combined horizontal/vertical test, required by § 25.562(b)(1) and these special conditions, must be conducted with a Hybrid II ATD (49 CFR part 572, subpart B, as specified in § 25.562), or equivalent, occupying each seat position.
3. Restraint systems:
a. If inflatable restraint systems are used, they must be active during all dynamic tests conducted to show compliance with § 25.562.
b. The design and installation of seat-belt buckles must prevent unbuckling due to applied inertial forces or impact of the hands/arms of the occupant during an emergency landing.
4. Additional performance measures applicable to tests and rational analysis conducted to show compliance with §§ 25.562 and 25.785 for side-facing seats:
a.
b.
c.
d.
e.
f.
i. The upper-neck tension force at the occipital condyle (O.C.) location must be less than 405 lb (1,800 N).
ii. The upper-neck compression force at the O.C. location must be less than 405 lb (1,800 N).
iii. The upper-neck bending torque about the ATD x-axis at the O.C.
iv. The upper-neck resultant shear force at the O.C. location must be less than 186 lb (825 N).
g.
h.
i.
ii.
5. For seats with an airbag system in the shoulder belts, show that the airbag system in the shoulder belt will deploy and provide protection under crash conditions where it is necessary to prevent serious injury. The means of protection must take into consideration a range of stature from a 2-year-old child to a 95th percentile male. The airbag system in the shoulder belt must provide a consistent approach to energy absorption throughout that range of occupants. When the seat system includes an airbag system, that system must be included in each of the certification tests as it would be installed in the airplane. In addition, the following situations must be considered:
a. The seat occupant is holding an infant.
b. The seat occupant is a pregnant woman.
6. The airbag system in the shoulder belt must provide adequate protection for each occupant regardless of the number of occupants of the seat assembly, considering that unoccupied seats may have an active airbag system in the shoulder belt.
7. The design must prevent the airbag system in the shoulder belt from being either incorrectly buckled or incorrectly installed, such that the airbag system in the shoulder belt would not properly deploy. Alternatively, it must be shown that such deployment is not hazardous to the occupant, and will provide the required injury protection.
8. It must be shown that the airbag system in the shoulder belt is not susceptible to inadvertent deployment as a result of wear and tear, or inertial loads resulting from in-flight or ground maneuvers (including gusts and hard landings), and other operating and environmental conditions (vibrations, moisture, etc.) likely to occur in service.
9. Deployment of the airbag system in the shoulder belt must not introduce injury mechanisms to the seated occupant, or result in injuries that could impede rapid egress. This assessment should include an occupant whose belt is loosely fastened.
10. It must be shown that inadvertent deployment of the airbag system in the shoulder belt, during the most critical part of the flight, will either meet the requirement of § 25.1309(b) or not cause a hazard to the airplane or its occupants.
11. It must be shown that the airbag system in the shoulder belt will not impede rapid egress of occupants 10 seconds after airbag deployment.
12. The airbag system must be protected from lightning and high-intensity radiated fields (HIRF). The threats to the airplane specified in existing regulations regarding lightning, § 25.1316, and HIRF, § 25.1317, are incorporated by reference for the purpose of measuring lightning and HIRF protection.
13. The airbag system in the shoulder belt must function properly after loss of normal aircraft electrical power, and after a transverse separation of the fuselage at the most critical location. A separation at the location of the airbag system in the shoulder belt does not have to be considered.
14. It must be shown that the airbag system in the shoulder belt will not release hazardous quantities of gas or particulate matter into the cabin.
15. The airbag system in the shoulder-belt installation must be protected from the effects of fire such that no hazard to occupants will result.
16. A means must be available for a crewmember to verify the integrity of the airbag system in the shoulder-belt activation system prior to each flight, or it must be demonstrated to reliably operate between inspection intervals. The FAA considers that the loss of the airbag-system deployment function alone (
17. The inflatable material may not have an average burn rate of greater than 2.5 inches/minute when tested using the horizontal flammability test defined in part 25, appendix F, part I, paragraph (b)(5).
18. The airbag system in the shoulder belt, once deployed, must not adversely affect the emergency-lighting system (
Federal Aviation Administration (FAA), Department of Transportation (DOT).
Final rule; request for comments.
We are publishing a new airworthiness directive (AD) for Bell Helicopter Textron Canada Limited (Bell) Model 429 helicopters. This AD was sent previously to all known U.S. owners and operators of these helicopters as Emergency AD 2018-16-51, dated July 26, 2018, which superseded Emergency AD 2018-15-51, dated July 20, 2018. This AD requires inspecting the tail rotor (T/R) gearbox installation, inspecting the T/R gearbox retaining hardware and support attachment point areas, and replacing each nut. This AD is prompted by two reports of T/R gearbox assemblies loosely attached to the gearbox support. The actions of this AD are intended to address an unsafe condition on these products.
This AD becomes effective November 6, 2018 to all persons except those persons to whom it was made immediately effective by Emergency AD 2018-16-51, issued on July 26, 2018, which contains the requirements of this AD.
We must receive comments on this AD by December 21, 2018.
You may send comments by any of the following methods:
•
•
•
•
You may examine the AD docket on the internet at
For service information identified in this final rule, contact Bell Helicopter Textron Canada Limited, 12,800 Rue de l'Avenir, Mirabel, Quebec J7J1R4; telephone (450) 437-2862 or (800) 363-8023; fax (450) 433-0272; 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
This AD is a final rule that involves requirements affecting flight safety, and we did not provide you with notice and an opportunity to provide your comments prior to it becoming effective. However, 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 resulted from adopting this AD. The most helpful comments reference a specific portion of the AD, 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 them 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 rulemaking during the comment period. We will consider all the comments we receive and may conduct additional rulemaking based on those comments.
Transport Canada, which is the aviation authority for Canada, issued Emergency AD No. CF-2018-18, dated July 11, 2018, to correct an unsafe condition for Bell Model 429 helicopters. Transport Canada advises of two reports of T/R gearbox assemblies loosely attached to the gearbox support. According to Transport Canada, this condition could lead to structural damage and possible loss of control of the helicopter.
As a result, on July 20, 2018, we issued Emergency AD 2018-15-51 (Emergency AD 2018-15-51), which required inspecting the T/R gearbox installation for looseness, visually inspecting the T/R gearbox retaining hardware and support attachment point areas, and torque inspecting the gearbox retaining nuts. Depending on the inspection results, Emergency AD 2018-15-51 required replacing or repairing the affected parts in accordance with FAA-approved procedures. Emergency AD 2018-15-51 was sent previously to all known U.S. owners and operators of these helicopters. The actions in Emergency AD 2018-15-51 were intended to prevent detachment of the T/R gearbox, loss of T/R control, and loss of control of the helicopter.
After we issued Emergency AD 2018-15-51, we discovered an error in the replacement nut P/N. The required replacement nut P/N is NAS9926-6L; not NAS9926-5L as incorrectly stated in Emergency AD 2018-15-51. Therefore, on July 26, 2018, we issued Emergency AD 2018-16-51 to supersede Emergency AD 2018-15-51 to correct the nut P/N. Emergency AD 2018-16-51 otherwise retains all of the requirements of Emergency AD 2018-15-51. Emergency AD 2018-16-51 was also sent previously to all known U.S. owners and operators of these helicopters.
These helicopters have been approved by the aviation authority of Canada and are approved for operation in the United States. Pursuant to our bilateral agreement with Canada, Transport Canada, its technical representative, has notified us of the unsafe condition described in the Transport Canada AD. We are issuing this AD because we evaluated all information provided by Transport Canada and determined the unsafe condition exists and is likely to exist or develop on other helicopters of the same type design.
We reviewed Bell Alert Service Bulletin 429-18-40, dated July 6, 2018, which specifies a one-time inspection of the T/R gearbox installation and a one-time visual and torque inspection of the six installation attachment points. This service information also specifies contacting Bell Product Support Engineering with the results of the T/R gearbox installation inspection, any findings of the visual inspection, and the results of the torque inspection.
This AD requires inspecting the T/R gearbox installation for looseness, visually inspecting the T/R gearbox retaining hardware and each support attachment point area, and torque inspecting each gearbox retaining nut. Depending on the inspection results, this AD requires replacing or repairing the affected parts in accordance with FAA-approved procedures.
The Transport Canada AD applies to helicopters with specific serial numbers, whereas this AD applies to all Model 429 helicopters. The Transport Canada AD includes a calendar based compliance time, whereas this AD does not. The Transport Canada AD requires reporting certain information to Bell Product Support Engineering and this AD does not. If there is looseness, this AD requires performing the visual inspection and torque inspection before further flight, while the Transport Canada AD requires contacting Bell. Lastly, if the torque of a T/R gearbox retaining nut is below 160 in-lbs (19 Nm), this AD requires removing the T/R gearbox and inspecting the mounting surfaces and retaining hardware, while the Transport Canada AD requires contacting Bell.
We consider this AD to be an interim action. If final action is later identified, we might consider further rulemaking then.
We estimate that this AD affects 90 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 $85.00 per work-hour.
Inspecting the T/R gearbox installation takes about 0.25 work-hour for an estimated cost of $21 per helicopter and $1,890 for the U.S. fleet. Inspecting the T/R gearbox retaining hardware and the support attachment points takes about 0.5 work-hour for an estimated cost of $43 per helicopter and $3,870 for the U.S. fleet. Replacing the nuts takes about 1 work-hour and parts cost about $20 for an estimated cost of $105 per helicopter and $9,450 for the U.S. fleet.
An unsafe condition exists that required the immediate adoption of Emergency AD 2018-16-51, issued on July 26, 2018, to all known U.S. owners and operators of these helicopters. The FAA found that the risk to the flying public justified waiving notice and comment prior to adoption of this rule because there are required actions that must be completed before further flight and within 5 hours time-in-service. These conditions still exist and the AD is hereby published in the
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
We determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed, I certify that this AD:
1. Is not a “significant regulatory action” under Executive Order 12866;
2. Is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979);
3. Will not affect intrastate aviation in Alaska 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 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 amends 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
This AD applies to Model 429 helicopters, certificated in any category.
This AD defines the unsafe condition as a loose tail rotor (T/R) gearbox support attachment point. This condition could result in detachment of the T/R gearbox, loss of T/R control, and loss of control of the helicopter.
This AD requires the same actions as Emergency AD 2018-16-51, dated July 26, 2018, which superseded Emergency AD 2018-15-51, dated July 20, 2018.
This AD becomes effective November 6, 2018 to all persons except those persons to whom it was made immediately effective by Emergency AD 2018-16-51, issued on July 26, 2018, which contains the requirements of this AD.
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) Before further flight, inspect for looseness of the T/R gearbox installation to the T/R gearbox structural support by moving the T/R gearbox output shaft in an upward and downward direction. If the T/R gearbox installation is loose, before further flight, complete the actions required by paragraphs (f)(2)(i) and (ii) of this AD.
(2) Within 5 hours time-in-service, unless already completed as required by paragraph (f)(1) of this AD:
(i) Visually inspect the T/R gearbox retaining hardware and each support attachment point area for evidence of fretting, a crack, and incorrect installation. If there is any evidence of fretting, a crack, or incorrect installation, before further flight, repair in accordance with FAA-approved procedures.
(ii) Inspect each T/R gearbox retaining nut by applying 160 in-lbs (19 Nm) of torque. If the torque of a T/R gearbox retaining nut is below 160 in-lbs (19 Nm), before further flight:
(A) Remove the T/R gearbox and inspect each stud for proper staking, each stud thread for uniformity, each mounting surface for evidence of fretting and cracking, and each mounting hole for elongation. If a stud is not properly staked, a stud thread is not uniform, a mounting surface has evidence of fretting or cracking, or a mount hole is elongated, before further flight, replace the affected parts or repair in accordance with FAA-approved procedures.
(B) Replace each nut with nut part number NAS9926-6L and apply a torque of 160 in-lbs.
(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.
(1) Bell Alert Service Bulletin 429-18-40, dated July 6, 2018, which is not incorporated
(2) The subject of this AD is addressed in Transport Canada AD No. CF-2018-18, dated July 11, 2018. You may view the Transport Canada AD on the internet at
Joint Aircraft Service Component (JASC) Code: 6520, Tail Rotor Gearbox.
Federal Aviation Administration (FAA), DOT.
Final rule.
This rule amends, suspends, or removes Standard Instrument Approach Procedures (SIAPs) and associated Takeoff Minimums and Obstacle Departure Procedures for operations at certain airports. These regulatory actions are needed because of the adoption of new or revised criteria, or because of changes occurring in the National Airspace System, such as the commissioning of new navigational facilities, adding new obstacles, or changing air traffic requirements. These changes are designed to provide for the safe and efficient use of the navigable airspace and to promote safe flight operations under instrument flight rules at the affected airports.
This rule is effective October 22, 2018. The compliance date for each SIAP, associated Takeoff Minimums, and ODP is specified in the amendatory provisions.
The incorporation by reference of certain publications listed in the regulations is approved by the Director of the Federal Register as of October 22, 2018.
Availability of matter incorporated by reference in the amendment is as follows:
1. U.S. Department of Transportation, Docket Ops-M30, 1200 New Jersey Avenue SE, West Bldg., Ground Floor, Washington, DC, 20590-0001;
2. The FAA Air Traffic Organization Service Area in which the affected airport is located;
3. The office of Aeronautical Navigation Products, 6500 South MacArthur Blvd., Oklahoma City, OK 73169 or,
4. The National Archives and Records Administration (NARA).
For information on the availability of this material at NARA, call 202-741-6030, or go to:
All SIAPs and Takeoff Minimums and ODPs are available online free of charge. Visit the National Flight Data Center online at
Thomas J. Nichols, Flight Procedure Standards Branch (AFS-420)Flight Technologies and Procedures Division, Flight Standards Service, Federal Aviation Administration, Mike Monroney Aeronautical Center, 6500 South MacArthur Blvd., Oklahoma City, OK. 73169 (Mail Address: P.O. Box 25082 Oklahoma City, OK. 73125) telephone: (405) 954-4164.
This rule amends Title 14, Code of Federal Regulations, Part 97 (14 CFR part 97) by amending the referenced SIAPs. The complete regulatory description of each SIAP is listed on the appropriate FAA Form 8260, as modified by the National Flight Data Center (NFDC)/Permanent Notice to Airmen (P-NOTAM), and is incorporated by reference under 5 U.S.C. 552(a), 1 CFR part 51, and 14 CFR 97.20. The large number of SIAPs, their complex nature, and the need for a special format make their verbatim publication in the
This amendment provides the affected CFR sections, and specifies the SIAPs and Takeoff Minimums and ODPs with their applicable effective dates. This amendment also identifies the airport and its location, the procedure and the amendment number.
The material incorporated by reference is publicly available as listed in the
The material incorporated by reference describes SIAPs, Takeoff Minimums and ODPs as identified in the amendatory language for part 97 of this final rule.
This amendment to 14 CFR part 97 is effective upon publication of each separate SIAP and Takeoff Minimums and ODP as amended in the transmittal. For safety and timeliness of change considerations, this amendment incorporates only specific changes contained for each SIAP and Takeoff Minimums and ODP as modified by FDC permanent NOTAMs.
The SIAPs and Takeoff Minimums and ODPs, as modified by FDC permanent NOTAM, and contained in this amendment are based on the criteria contained in the U.S. Standard for Terminal Instrument Procedures (TERPS). In developing these changes to SIAPs and Takeoff Minimums and ODPs, the TERPS criteria were applied only to specific conditions existing at the affected airports. All SIAP amendments in this rule have been previously issued by the FAA in a FDC NOTAM as an emergency action of immediate flight safety relating directly to published aeronautical charts.
The circumstances that created the need for these SIAP and Takeoff Minimums and ODP amendments require making them effective in less than 30 days.
Because of the close and immediate relationship between these SIAPs, Takeoff Minimums and ODPs, and safety in air commerce, I find that notice and public procedure under 5 U.S.C. 553(b) are impracticable and contrary to the public interest and, where applicable, under 5 U.S.C. 553(d), good cause exists for making these SIAPs effective in less than 30 days.
The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore—(1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT regulatory Policies and Procedures (44 FR 11034; February 26, 1979) ; and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. For the same reason, the FAA certifies that this amendment will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air traffic control, Airports, Incorporation by reference, Navigation (air).
Accordingly, pursuant to the authority delegated to me, Title 14, Code of Federal Regulations, part 97, (14 CFR part 97), is amended by amending Standard Instrument Approach Procedures and Takeoff Minimums and ODPs, effective at 0901 UTC on the dates specified, as follows:
49 U.S.C. 106(f), 106(g), 40103, 40106, 40113, 40114, 40120, 44502, 44514, 44701, 44719, 44721-44722.
By amending: § 97.23 VOR, VOR/DME, VOR or TACAN, and VOR/DME or TACAN; § 97.25 LOC, LOC/DME, LDA, LDA/DME, SDF, SDF/DME; § 97.27 NDB, NDB/DME; § 97.29 ILS, ILS/DME, MLS, MLS/DME, MLS/RNAV; § 97.31 RADAR SIAPs; § 97.33 RNAV SIAPs; and § 97.35 COPTER SIAPs, Identified as follows:
Federal Aviation Administration (FAA), DOT.
Final rule.
This rule establishes, amends, suspends, or removes Standard Instrument Approach Procedures (SIAPs) and associated Takeoff Minimums and Obstacle Departure Procedures (ODPs) for operations at certain airports. These regulatory actions are needed because of the adoption of new or revised criteria, or because of changes occurring in the National Airspace System, such as the commissioning of new navigational facilities, adding new obstacles, or changing air traffic requirements. These changes are designed to provide safe and efficient use of the navigable airspace and to promote safe flight operations under instrument flight rules at the affected airports.
This rule is effective October 22, 2018. The compliance date for each SIAP, associated Takeoff Minimums, and ODP is specified in the amendatory provisions.
The incorporation by reference of certain publications listed in the regulations is approved by the Director of the
Availability of matters incorporated by reference in the amendment is as follows:
1. U.S. Department of Transportation, Docket Ops-M30, 1200 New Jersey Avenue SE, West Bldg., Ground Floor, Washington, DC 20590-0001.
2. The FAA Air Traffic Organization Service Area in which the affected airport is located;
3. The office of Aeronautical Navigation Products, 6500 South MacArthur Blvd., Oklahoma City, OK 73169 or,
4. The National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to:
All SIAPs and Takeoff Minimums and ODPs are available online free of charge. Visit the National Flight Data Center at
Thomas J. Nichols, Flight Procedure Standards Branch (AFS-420), Flight Technologies and Programs Divisions, Flight Standards Service, Federal Aviation Administration, Mike Monroney Aeronautical Center, 6500 South MacArthur Blvd. Oklahoma City, OK. 73169 (Mail Address: P.O. Box 25082, Oklahoma City, OK 73125) Telephone: (405) 954-4164.
This rule amends Title 14 of the Code of Federal Regulations, Part 97 (14 CFR part 97), by establishing, amending, suspending, or removes SIAPS, Takeoff Minimums and/or ODPS. The complete regulatory description of each SIAP and its associated Takeoff Minimums or ODP for an identified airport is listed on FAA form documents which are incorporated by reference in this amendment under 5 U.S.C. 552(a), 1 CFR part 51, and 14 CFR part 97.20. The applicable FAA forms are FAA Forms 8260-3, 8260-4, 8260-5, 8260-15A, and 8260-15B when required by an entry on 8260-15A.
The large number of SIAPs, Takeoff Minimums and ODPs, their complex nature, and the need for a special format make publication in the
The material incorporated by reference is publicly available as listed in the
The material incorporated by reference describes SIAPS, Takeoff Minimums and/or ODPS as identified in the amendatory language for part 97 of this final rule.
This amendment to 14 CFR part 97 is effective upon publication of each separate SIAP, Takeoff Minimums and ODP as Amended in the transmittal. Some SIAP and Takeoff Minimums and textual ODP amendments may have been issued previously by the FAA in a Flight Data Center (FDC) Notice to Airmen (NOTAM) as an emergency action of immediate flight safety relating directly to published aeronautical charts.
The circumstances that created the need for some SIAP and Takeoff Minimums and ODP amendments may require making them effective in less than 30 days. For the remaining SIAPs and Takeoff Minimums and ODPs, an effective date at least 30 days after publication is provided.
Further, the SIAPs and Takeoff Minimums and ODPs contained in this amendment are based on the criteria contained in the U.S. Standard for Terminal Instrument Procedures (TERPS). In developing these SIAPs and Takeoff Minimums and ODPs, the TERPS criteria were applied to the conditions existing or anticipated at the affected airports. Because of the close and immediate relationship between these SIAPs, Takeoff Minimums and ODPs, and safety in air commerce, I find that notice and public procedure under 5 U.S.C. 553(b) are impracticable and contrary to the public interest and, where applicable, under 5 U.S.C 553(d), good cause exists for making some SIAPs effective in less than 30 days.
The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore—(1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26,1979) ; and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. For the same reason, the FAA certifies that this amendment will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air traffic control, Airports, Incorporation by reference, Navigation (air).
Accordingly, pursuant to the authority delegated to me, Title 14, Code of Federal Regulations, Part 97 (14 CFR part 97) is amended by establishing, amending, suspending, or removing Standard Instrument Approach Procedures and/or Takeoff Minimums and Obstacle Departure Procedures effective at 0901 UTC on the dates specified, as follows:
49 U.S.C. 106(f), 106(g), 40103, 40106, 40113, 40114, 40120, 44502, 44514, 44701, 44719, 44721-44722.
Department of Veterans Affairs.
Final rule.
The Department of Veterans Affairs (VA) is adopting as final an interim final rule published on June 19, 2015, to amend its adjudication regulation governing individuals presumed to have been exposed to certain herbicides. Specifically, VA expanded the regulation to include an additional group consisting of individuals who performed service in the Air Force or Air Force Reserve under circumstances in which they had regular and repeated contact with C-123 aircraft known to have been used to spray an herbicide agent (“Agent Orange”) during the Vietnam era. In addition, the regulation established a presumption that members of this group who later develop an Agent Orange presumptive condition were disabled during the relevant period of service, thus establishing that service as “active military, naval, or air service.” The effect of this action is to presume herbicide exposure for these individuals and to create a presumption that the individuals who are presumed exposed to herbicides during reserve service also meet the statutory definition of “veteran” (hereinafter, “veteran status”) for VA purposes and eligibility for some VA benefits.
Stephanie Li, Chief, Regulations Staff (211D), Compensation Service, Department of Veterans Affairs, 810 Vermont Avenue NW, Washington, DC 20420, (202) 461-9700. (This is not a toll-free telephone number.)
In a document published in the
The majority of public comments asserted a need for retroactive application of the effective date assigned for the interim final rule. Retroactivity is generally not favored in the law and an agency will not generally be considered to have authority to provide retroactive effect unless an exception to this general rule is provided via an express statutory delegation of authority.
Even to the extent VA's rulemaking authority under 38 U.S.C. 501 includes authority to issue retroactive regulations, and assuming such an understanding can be reconciled with section 5110(g), VA declines to do so in this matter. Even if VA's rulemaking authority extends to assigning a retroactive effective date in the abstract, doing so is nevertheless inconsistent with the intent of section 5110(g) and would certainly be inconsistent with VA's usual and longstanding practice to make substantive rules effective prospectively. Maintaining a general policy of applying new regulations prospectively helps ensure that all new liberalizing regulations are applied in a fair and consistent manner. The United States Court of Appeals for the Federal Circuit has reviewed this authority and held that VA did not act unreasonably in using a prospective effective date for a liberalizing regulation rather than a retroactive effective date in circumstance similar to this.
Multiple sub-categories were present within the broad category of requests for a retroactive effective date. Numerous commenters argued that this regulation is unnecessary as current VA policies and procedures already allow for establishing service-connected disability status based on exposure to residual dioxin aboard C-123 aircraft and the subsequent development of disabilities related thereto. Multiple commenters theorized that the regulation is unnecessary to establish presumption of exposure as an in-service injury during inactive duty training or active duty for training status. The comments referenced an opinion of VA's Office of General Counsel (OGC), VAOPGCPREC 4-2002, as a basis for establishing that the exposure to residual dioxin was an in-service “injury” sufficient to satisfy the criteria for service connection under 38 U.S.C. 101(24). Similarly, other comments received referenced another OGC opinion, VAOPGCPREC 08-2001, as a basis to establish occurrence of an “injury” for the purposes of establishing active service to satisfy section 101(24).
The two cited opinions and the argument that reservists can meet the statutory definition of “veteran” simply on the basis of injury are all inapposite to this rulemaking. Current law, specifically 38 U.S.C. 101(2), defines “veteran” as “a person who served in the active military, naval, or air service, and who was discharged or released therefrom under conditions other than dishonorable.” Section 101(24) then clarifies that “active military, naval, or air service” includes active duty for training during which an injury or disease is incurred or aggravated in the line of duty, or inactive duty for training during which an injury was incurred or aggravated in the line or duty or during which an acute myocardial infarction, a cardiac arrest, or a cerebrovascular accident occurs. Further, in both scenarios, section 101(24) requires that, “during” the referenced duty period, the putative veteran “was disabled or died” from a covered injury or disease. Thus, two discrete elements are required before VA can conclude that active duty for training (ADT) or inactive duty training (IDT) are considered active service: Injury (or in the case of ADT, disease as well, or in the case of IDT, the events specified in section 101(24)(C)(ii)) incurred or aggravated in the line of duty, and incurrence of disability during such duty period from that same covered injury or disease. Although the commenters are correct in that VA stated in the interim final rule that exposure to Agent Orange constitutes injury for veteran status purposes, insofar as the commenters argue that injury alone is sufficient to establish veteran status they are incorrect. In both ADT and IDT cases, disability must be incurred during the period of service.
Both of the OGC opinions cited by commenters addressed whether specific incidents during service were legally sufficient to satisfy the definition of injury in section 101(24). The opinions did not address whether the injuries at issue could or did cause a disability or death during the same period of service, much less create a presumption that the injuries at issue would do so.
Multiple comments referenced a March 2013 correspondence from the Joint Services Records Research Center (JSRRC) to VA. JSRRC had cited the findings of a study by the Agency for Toxic Substances and Disease Registry (ATSDR) as relevant documentation establishing exposure to residual dioxin. The commenters requested that this memorandum be utilized as a basis for a retroactive effective date. Similarly, multiple comments referenced the 2015 findings of the Institute of Medicine (IOM) and requested that the date of these findings be utilized as a basis for the effective date of this regulation.
VA finds no basis to utilize the JSRRC correspondence or the IOM findings to establish an earlier effective date for the regulation. For all regulations in which VA has established a presumption of exposure, there is a body of scientific evidence that must be considered and ultimately informs the decision to establish the presumption of exposure. This body of scientific evidence, by logical necessity, predates the effective date of the regulation. Exposure aboard contaminated C-123 aircraft is no different. As discussed above, to the extent VA has legal authority to establish a retroactive effective date, it is unquestionably the well-established practice of VA and Congress to establish liberalizing regulations and statutes benefitting other groups of veterans with prospective effective dates. Therefore, no change is warranted based on any of these multiple theories asserted in support of assigning a retroactive effective date for this regulation.
Some comments referenced prior VA decisions to grant service-connected disability benefits based on exposure during inactive or active duty for training status aboard contaminated C-123 aircraft and utilized this as a basis for the argument to assign an earlier effective date for this regulation. Prior decisions granting benefits as described were made on the basis of the facts found in the individual case and the law that existed at the time, and are not a means for assigning an effective date for a regulation. As previously noted, under 38 U.S.C. 5110(g), effective dates “shall be fixed in accordance with the facts found but shall not be earlier than the effective date of the Act or administrative issue.” The prior cases referenced in the comments were all granted on the basis of individual facts found, and as already discussed above, the current regulation establishes entitlement on a presumptive basis. Thus, no change is warranted based on these comments.
Some commenters objected to the regulation on the basis that the regulation imposes an additional challenge for cases already on appeal as veteran status must now be considered. Determining veteran status is always part of the claims process. Although veteran status may not be directly addressed and discussed in the adjudication of every claim or an appeal, it is one of many determinations that must be made along the path of considering entitlement to any VA benefit, and is frequently at issue in claims arising from periods of active duty for training or inactive duty training.
An additional category of comments objected to the effective date on the basis that failure to allow for retroactive benefits results in denial of due process for those individuals who had previously submitted claims. For a denial of due process to occur, there must be a property interest, such as entitlement to a benefit, and deprivation of the property interest flowing from the defective process. At the time any claim was received prior to the effective date of this regulation, presumptive entitlement to a benefit did not exist as a matter of law (38 U.S.C. 5110(g) and 38 CFR 3.114). Due process serves to protect property interests that are recognized or created by the law—it does not itself create property interests.
Multiple comments referenced what was viewed as unfavorable treatment of reserve service as compared to individuals who established status as a veteran after other types of service. As described in the explanation of responses to effective date comments, the term “veteran” is defined in existing statutes. This rule serves as a vehicle to help members of the Air Force Reserve establish that their herbicide-related disease was incurred during active service. VA is without authority to ignore the statutory definition of the term “veteran” regardless of whether that term treats reserve service differently than other types of service. Therefore, no change is warranted based on these comments.
VA received comments requesting action in accordance with the effective date rules governed by the class action case of
VA received four comments in which the commenter objected to concession of exposure based on a lack of and/or faulty scientific evidence confirming actual exposure to residual dioxin. One of these comments also cited a 20-year Air Force Health Study that showed no correlation between exposure in crews participating in Operation Ranch Hand and those disabilities that VA presumes associated with herbicide exposure. VA has based its decision to add presumptions for C-123 veterans on the entire body of relevant evidence, including the findings of the February 24, 2015, IOM report “Post-Vietnam Dioxin Exposure in Agent Orange-Contaminated C-123 Aircraft.” The report found evidence of potentially harmful exposure to residual dioxin for those Air Force Reservists who worked aboard contaminated, former Operation Ranch Hand C-123 aircraft. VA considered the comments and evidence cited by the commenters, but determined that they are not sufficient to outweigh the IOM's finding that “[Air Force] Reservists working in [Operation Ranch Hand] C-123s were exposed (in the technical sense of the word of having bodily contact with the chemicals) to the components of Agent Orange to some extent.” Therefore, no change is warranted based on these comments.
Further, with regard to the comment questioning the validity of the presumptive correlation between exposure to residual dioxin and the subsequent development of diseases, the IOM report clearly states and provides sufficient analysis to confirm that it is plausible that Air Force Reservists “would have experienced some exposure to chemicals from herbicide residue when working inside [Operation Ranch Hand] C-123s.” The IOM committee reported that “[n]o matter what” decontamination methods were used, “TCDD and phenoxy herbicide residues were still detected 30 years later in several of the C-123 aircraft at levels in excess of international guidelines.” TCDD refers to the dioxin, an unintended contaminant in Agent Orange, which was later determined to be a human carcinogen. The IOM was able to find sufficient sampling data to demonstrate that the C-123s experienced long-term contamination with Agent Orange and TCDD. The report further explains that the available data was sufficient to suggest that “the C-123s did contribute to some adverse health consequences among the [Air Force] Reservists who worked in [Operation Ranch Hand] C-123s.” It has been longstanding VA policy to presume service-connection for certain disabilities determined to have been related to exposure to Agent Orange or related herbicides during military service.
Two comments were received requesting Agent Orange Registry examinations. Entitlement to Agent Orange Registry examinations is not within the scope of this rule making. Agent Orange Registry examinations are made available to individuals who may have been exposed to herbicides during a military operation or as a result of testing, transporting, or spraying herbicides for military purposes. This rulemaking does not impact the availability of Agent Orange Registry examinations. Consequently, no change is made based upon these comments.
Several comments were received pertaining to exposure aboard C-123 aircraft at specific locations. This regulation does not establish criteria based on specific locations, but rather based on the type of service (Air Force or Air Force Reserve) and circumstances of that service (regular and repeated contact with C-123 aircraft known to have been used to spray Agent Orange during the Vietnam era). Specifically, the amended regulation establishes that VA will presume exposure to herbicides and in-service injury and incurrence of disability for individuals who suffer from specified herbicide-related diseases and “regularly and repeatedly operated, maintained, or served onboard C-123 aircraft known to have been used to spray an herbicide agent during the Vietnam era.” It further clarifies that the individual had to have been assigned to an Air Force or Air Force Reserve squadron that was permanently assigned one of the affected aircraft, and that he/she had an Air Force specialty code indicating duties as a flight, ground maintenance, or medical crew member. VA procedures have been established based upon the interim final rule to set forth this criteria in order to determine whether an individual was exposed based on the circumstances of service. Therefore, no change is warranted in response to these comments.
One commenter requested that breast cancer be designated as a disability presumptively related to exposure to residual dioxin on C-123 aircraft. This comment is outside the scope of this rulemaking. This rulemaking establishes means for presuming exposure to herbicides and establishing veteran status. The designation of a presumptive relationship between herbicide exposure and the subsequent development of any type of disease, such as breast cancer, is not within the scope of this rulemaking. Consequently, no change is warranted based upon this comment. However, VA will continue to monitor relevant scientific and medical reports for conditions associated with exposure to certain herbicide agents. If, at a later date, there is sufficient
One comment was received requesting clarification of entitlement to survivor benefits within the rulemaking. Although clarification of entitlement to survivor benefits is not within the scope of this rulemaking in particular, we note that status to claim entitlement to survivor benefits is generally predicated on the basis of the survivor's relationship to a veteran, while the benefits that a survivor may claim can be dependent on the benefits to which that veteran was entitled. Whether a veteran's entitlement to benefits is established based in part on this liberalizing rule would not itself impact a suvivor's ability to claim benefits or the benefits to which the survivor would be entitled. No change is warranted based upon this comment.
Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, and other advantages; distributive impacts; and equity). Executive Order 13563 (Improving Regulation and Regulatory Review) emphasizes the importance of quantifying both costs and benefits, reducing costs, harmonizing rules, and promoting flexibility. Executive Order 12866 (Regulatory Planning and Review) defines a “significant regulatory action,” which requires review by the Office of Management and Budget (OMB), as “any regulatory action that is likely to result in a rule that may: (1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities; (2) Create a serious inconsistency or otherwise interfere with an action taken or planned by another agency; (3) Materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in this Executive Order.”
The economic, interagency, budgetary, legal, and policy implications of this regulatory action have been examined and it has been determined to be a significant regulatory action under Executive Order 12866, because it rasises novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in this Executive Order. VA's impact analysis can be found as a supporting document at
The Secretary hereby certifies that this final rule will not have a significant economic impact on a substantial number of small entities as they are defined in the Regulatory Flexibility Act (5 U.S.C. 601-612). This final rule will directly affect only individuals and will not directly affect small entities. Therefore, pursuant to 5 U.S.C. 605(b), this rulemaking is exempt from the initial and final regulatory flexibility analysis requirements of sections 603 and 604.
The Unfunded Mandates Reform Act of 1995 requires, at 2 U.S.C. 1532, that agencies prepare an assessment of anticipated costs and benefits before issuing any rule 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 (adjusted annually for inflation) in any one year. This final rule will have no such effect on State, local, and tribal governments, or on the private sector.
This regulatory action contains provisions constituting a collection of information under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
The Catalog of Federal Domestic Assistance numbers and titles for the programs affected by this document are 64.100, Automobiles and Adaptive Equipment for Certain Disabled Veterans and Members of the Armed Forces; 64.101, Burial Expenses Allowance for Veterans; 64.102, Compensation for Service-Connected Deaths for Veterans' Dependents; 64.104, Pension for Non-Service-Connected Disability for Veterans; 64.105, Pension to Veterans Surviving Spouses and Children; 64.106, Specially Adapted Housing for Disabled Veterans; 64.109, Veterans Compensation for Service-Connected Disability; and 64.110, Veterans Dependency and Indemnity Compensation for Service-Connected Death.
Administrative practice and procedure, Claims, Disability benefits, Health care, Pensions, Radioactive materials, Veterans, Vietnam.
The Secretary of Veterans Affairs, or designee, approved this document and authorized the undersigned to submit the document to the Office of the Federal Register for publication electronically as an official document of the Department of Veterans Affairs. Jacquelyn Hayes-Byrd, Acting Chief of Staff, Department of Veterans Affairs, approved this document on June 12, 2018, for publication.
Environmental Protection Agency (EPA).
Final rule; delegation of authority.
The Oklahoma Department of Environmental Quality (ODEQ) has submitted updated regulations for receiving delegation and approval of its program for the implementation and enforcement of certain National Emission Standards for Hazardous Air Pollutants (NESHAP) for all sources (both part 70 and non-part 70 sources), as provided for under previously approved delegation mechanisms. The updated state regulations incorporate by reference certain NESHAP promulgated by the EPA at parts 61 and 63, as they existed through September 1, 2016. The EPA is providing notice that it is taking final action to approve the delegation of certain NESHAP to ODEQ.
This rule is effective on November 21, 2018.
The EPA has established a docket for this action under Docket ID No. EPA-R06-OAR-2008-0063. All documents in the docket are listed on the
Mr. Rick Barrett (6MM-AP), (214) 665-7227; email:
Throughout this document wherever “we,” “us,” or “our” is used, we mean the EPA.
The background for this action is discussed in detail in our August 10, 2018, proposal (83 FR 39641). In that document we proposed to approve a request from the Oklahoma Department of Environmental Quality (ODEQ) to update its existing NESHAP regulations for receiving delegation and approval of its program for the implementation and enforcement of certain National Emission Standards for Hazardous Air Pollutants (NESHAP) for all sources (both part 70 and non-part 70 sources), as provided for under previously approved delegation mechanisms. We received five anonymous public comments on the proposed rulemaking action. The comments are posted to the docket (EPA-R06-OAR-2008-0063). None of the comments are relevant to our proposed rulemaking to approve ODEQ's request updating the delegation of certain NESHAP. Since these comments are not relevant to the specific action EPA proposed, the EPA will not be responding to these comments or making any changes to our proposed rulemaking because of these comments.
EPA is providing notice that it is taking final action to approve ODEQ's request updating the delegation of certain NESHAP. With this delegation, ODEQ has the primary responsibility to implement and enforce the delegated standards.
Section 112(l) of the CAA and 40 CFR part 63, subpart E, authorize the EPA to delegate authority for the implementation and enforcement of emission standards for hazardous air pollutants to a State or local agency that satisfies the statutory and regulatory requirements in subpart E. The hazardous air pollutant standards are codified at 40 CFR parts 61 and 63.
Section 112(l)(5) of the CAA requires the EPA to disapprove any program submitted by a State for the delegation of NESHAP standards if the EPA determines that:
(A) The authorities contained in the program are not adequate to assure compliance by the sources within the State with respect to each applicable standard, regulation, or requirement established under section 112;
(B) adequate authority does not exist, or adequate resources are not available, to implement the program;
(C) the schedule for implementing the program and assuring compliance by affected sources is not sufficiently expeditious; or
(D) the program is otherwise not in compliance with the guidance issued by the EPA under section 112(l)(2) or is not likely to satisfy, in whole or in part, the objectives of the CAA.
In carrying out its responsibilities under section 112(l), the EPA promulgated regulations at 40 CFR part 63, subpart E setting forth criteria for the approval of submitted programs. For example, in order to obtain approval of a program to implement and enforce Federal section 112 rules as promulgated without changes (straight delegation) for part 70 sources, a State must demonstrate that it meets the criteria of 40 CFR 63.91(d). 40 CFR 63.91(d)(3) provides that interim or final Title V program approval will satisfy the criteria of 40 CFR 63.91(d).
The NESHAP delegation for Oklahoma, as it applies to both part 70 and non-part 70 sources, was most recently approved on December 13, 2005 (70 FR 73595).
As to the NESHAP standards in 40 CFR parts 61 and 63, as part of its Title V submission ODEQ stated that it intended to use the mechanism of incorporation by reference to adopt unchanged Federal section 112 into its regulations. This commitment applied to both existing and future standards as
By letter dated June 25, 2018, the EPA received a request from ODEQ to update its existing NESHAP delegation.
All authorities not affirmatively and expressly delegated by this action are not delegated. These include the following part 61 and 63 authorities listed below:
• 40 CFR part 61, subpart B (National Emission Standards for Radon Emissions from Underground Uranium Mines);
• 40 CFR part 61, subpart H (National Emission Standards for Emissions of Radionuclides Other Than Radon From Department of Energy Facilities);
• 40 CFR part 61, subpart I (National Emission Standards for Radionuclide Emissions from Federal Facilities Other Than Nuclear Regulatory Commission Licensees and Not Covered by Subpart H);
• 40 CFR part 61, subpart K (National Emission Standards for Radionuclide Emissions from Elemental Phosphorus Plants);
• 40 CFR part 61, subpart Q (National Emission Standards for Radon Emissions from Department of Energy facilities);
• 40 CFR part 61, subpart R (National Emission Standards for Radon Emissions from Phosphogypsum Stacks);
• 40 CFR part 61, subpart T (National Emission Standards for Radon Emissions from the Disposal of Uranium Mill Tailings);
• 40 CFR part 61, subpart W (National Emission Standards for Radon Emissions from Operating Mill Tailings); and
• 40 CFR part 63, subpart J (National Emission Standards for Polyvinyl Choride and Copolymers Production).
In addition, the EPA regulations provide that we cannot delegate to a State any of the Category II Subpart A authorities set forth in 40 CFR 63.91(g)(2). These include the following provisions: § 63.6(g), Approval of Alternative Non-Opacity Standards; § 63.6(h)(9), Approval of Alternative Opacity Standards; § 63.7(e)(2)(ii) and (f), Approval of Major Alternatives to Test Methods; § 63.8(f), Approval of Major Alternatives to Monitoring; and § 63.10(f), Approval of Major Alternatives to Recordkeeping and Reporting. Also, some part 61 and part 63 standards have certain provisions that cannot be delegated to the States. Furthermore, no authorities are delegated that require rulemaking in the
All inquiries and requests concerning implementation and enforcement of the excluded standards in the State of Oklahoma should be directed to the EPA Region 6 Office.
In addition, this delegation to ODEQ to implement and enforce certain NESHAP does not extend to sources or activities located in Indian country, as defined in 18 U.S.C. 1151. Oklahoma is not seeking delegation for such areas, and neither the EPA nor ODEQ is aware of any existing facilities in Indian country subject to the NESHAP being delegated. ODEQ may submit a request to expand this program to non-reservation areas of Indian country in the future, at which time the EPA would evaluate the request through the appropriate process.
In approving the NESHAP delegation, ODEQ will obtain concurrence from the EPA on any matter involving the interpretation of section 112 of the CAA or 40 CFR parts 61 and 63 to the extent that implementation or enforcement of these provisions have not been covered by prior EPA determinations or guidance.
We retain the right, as provided by CAA section 112(l)(7) and 40 CFR 63.90(d)(2), to enforce any applicable emission standard or requirement established under section 112. In addition, the EPA may enforce any federally approved State rule, requirement, or program under 40 CFR 63.90(e) and 63.91(c)(1)(i). The EPA also has the authority to make certain decisions under the General Provisions (subpart A) of parts 61 and 63. We are delegating to the ODEQ some of these authorities, and retaining others, as explained in sections VI and VII above. In addition, the EPA may review and disapprove State determinations and subsequently require corrections.
Furthermore, we retain any authority in an individual emission standard that may not be delegated according to provisions of the standard. Also, listed in footnote 2 of the part 63 delegation table at the end of this rule are the authorities that cannot be delegated to any State or local agency which we therefore retain.
Finally, we retain the authorities stated in the original delegation agreement.
ODEQ must provide any additional compliance related information to EPA, Region 6, Office of Enforcement and Compliance Assurance within 45 days of a request under 40 CFR 63.96(a). In receiving delegation for specific General
The EPA oversees ODEQ's decisions to ensure the delegated authorities are being adequately implemented and enforced. We will integrate oversight of the delegated authorities into the existing mechanisms and resources for oversight currently in place. If, during oversight, we determine that ODEQ made decisions that decreased the stringency of the delegated standards, then ODEQ shall be required to take corrective actions and the source(s) affected by the decisions will be notified, as required by 40 CFR 63.91(g)(1)(ii) and (b). Our oversight authorities allow us to initiate withdrawal of the program or rule if the corrective actions taken are insufficient.
For the delegated NESHAP standards and authorities covered by this action, sources would submit all of the information required pursuant to the general provisions and the relevant subpart(s) of the delegated NESHAP (40 CFR parts 61 and 63) directly to the ODEQ at the following address: State of Oklahoma, Department of Environmental Quality, Air Quality Division, P.O. Box 1677, Oklahoma City, Oklahoma 73101-1677. The ODEQ is the primary point of contact with respect to delegated NESHAP. Sources do not need to send a copy to the EPA. The EPA Region 6 waives the requirement that notifications and reports for delegated standards be submitted to EPA in addition to ODEQ in accordance with 40 CFR 63.9(a)(4)(ii) and 63.10(a)(4)(ii).
As stated in previous NESHAP delegation actions, the EPA has approved Oklahoma's mechanism of incorporation by reference of NESHAP standards into ODEQ regulations, as they apply to both part 70 and non-part 70 sources.
EPA is taking final action to approve an update to the Oklahoma NESHAP delegation that would provide the ODEQ with the authority to implement and enforce certain newly incorporated NESHAP promulgated by the EPA, and amendments to existing standards currently delegated, as they existed though September 1, 2016. As requested in ODEQ's June 25, 2018 letter, this final delegation to ODEQ does not extend to sources or activities located in Indian country, as defined in 18 U.S.C. 1151.
Under the CAA, the Administrator has the authority to approve section 112(l) submissions that comply with the provisions of the Act and applicable Federal regulations. In reviewing section 112(l) submissions, the EPA's role is to approve state choices, provided that they meet the criteria and objectives of the CAA and of the EPA's implementing regulations. Accordingly, this final action merely approves the State's request as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this final action:
• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
• does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Public Law 104-4);
• does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• is not an economically significant regulatory action based on health or
• is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and
• does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
Environmental protection, Administrative practice and procedure, Air pollution control, Arsenic, Benzene, Beryllium, Hazardous substances, Mercury, Intergovernmental relations, Reporting and recordkeeping requirements, Vinyl chloride.
Environmental protection, Administrative practice and procedure, Air pollution control, Hazardous substances, Intergovernmental relations, Reporting and recordkeeping requirements.
42 U.S.C. 7401
For the reasons stated in the preamble, 40 CFR parts 61 and 63 are amended as follows:
42 U.S.C. 7401
(b) * * *
(38) State of Oklahoma, Oklahoma Department of Environmental Quality, Air Quality Division, P.O. Box 1677, Oklahoma City, OK 73101-1677. For a list of delegated standards for Oklahoma see paragraph (c)(6) of this section.
(c) * * *
(6) * * *
(iv)
42 U.S.C. 7401
(a) * * *
(37) * * *
(i) The following table lists the specific part 63 standards that have been delegated unchanged to the Oklahoma Department of Environmental Quality for all sources. The “X” symbol is used to indicate each subpart that has been delegated. The delegations are subject to all of the conditions and limitations set forth in Federal law, regulations, policy, guidance, and determinations. Some authorities cannot be delegated and are retained by EPA. These include certain General Provisions authorities and specific parts of some standards. Any amendments made to these rules after September 1, 2016 are not delegated.
Federal Communications Commission.
Final rule; announcement of effective date.
In this document, the Commission announces that the Office of Management and Budget (OMB) has approved, for a period of three years, the information collection associated with the Commission's
The amendment to 47 CFR 27.1310 published at 80 FR 71731, November 17, 2015, are effective October 22, 2018.
Aspasia Paroutsas, Office of Engineering and Technology, at (202) 418-7285, or email:
This document announces that, on April 3, 2017, OMB approved, for a period of three years, the information collection requirements relating to the harmful interference rule contained in the Commission's
To request materials in accessible formats for people with disabilities (Braille, large print, electronic files, audio format), send an email to
As required by the Paperwork Reduction Act of 1995 (44 U.S.C. 3507), the FCC is notifying the public that it received final OMB approval on April 3, 2017, for the information collection requirements contained in the modifications to the Commission's rules in 47 CFR part 27.
Under 5 CFR part 1320, an agency may not conduct or sponsor a collection of information unless it displays a current, valid OMB Control Number.
No person shall be subject to any penalty for failing to comply with a collection of information subject to the Paperwork Reduction Act that does not display a current, valid OMB Control Number. The OMB Control Number is 3060-1229.
The foregoing notice is required by the Paperwork Reduction Act of 1995, Public Law 104-13, October 1, 1995, and 44 U.S.C. 3507.
The total annual reporting burdens and costs for the respondents are as follows:
On October 26, 2015, the Federal Communications Commission released a Third Report and Order and First Order on Reconsideration, FCC 15-141, published at 80 FR 71731, November 17, 2015,
Nuclear Regulatory Commission.
Proposed rule.
The U.S. Nuclear Regulatory Commission (NRC) is proposing to amend its spent fuel storage regulations by revising the NAC International NAC-UMS® listing within the “List of approved spent fuel storage casks” to include Amendment No. 6 to Certificate of Compliance (CoC) No. 1015. Amendment No. 6 revises the CoC's technical specifications (TSs) to: Remove a redundant requirement for inspection of the concrete cask and canister; revise a limiting condition of operation (LCO) for heat removal to clarify that “LCO not met” means that the concrete heat removal system is inoperable; remove an inspection requirement that is already covered by LCO surveillance requirements for off-normal, accident, or natural phenomenon events; and clarify that “immediate” restoration of a concrete cask's heat removal capabilities means “within the design-basis time limit” in Section 11.2.13 of the Final Safety Analysis Report (FSAR), “or within the time limit for a less than design-basis heat load case, as evaluated.” Amendment No. 6 also clarifies that an LCO for loaded cask surface dose rates applies prior to storage conditions, when dose rates will be highest.
Submit comments by November 21, 2018. Comments received after this date will be considered if it is practical to do so, but the NRC is able to ensure consideration only for comments received on or before this date.
You may submit comments by any of the following methods:
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For additional direction on obtaining information and submitting comments, see “Obtaining Information and Submitting Comments” in the
Bernard H. White, Office of Nuclear Material Safety and Safeguards; telephone: 301-415-6577; email:
Please refer to Docket ID NRC-2018-0075 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:
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Please include Docket ID NRC-2018-0075 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
Because the NRC considers this action to be non-controversial, the NRC is publishing this proposed rule concurrently with a direct final rule in the Rules and Regulations section of this issue of the
A significant adverse comment is a comment where the commenter explains why the rule would be inappropriate, including challenges to the rule's underlying premise or approach, or would be ineffective or unacceptable without a change. A comment is adverse and significant if:
(1) The comment opposes the rule and provides a reason sufficient to require a substantive response in a notice-and-comment process. For example, a substantive response is required when:
(a) The comment causes the NRC staff to reevaluate (or reconsider) its position or conduct additional analysis;
(b) The comment raises an issue serious enough to warrant a substantive response to clarify or complete the record; or
(c) The comment raises a relevant issue that was not previously addressed or considered by the NRC staff.
(2) The comment proposes a change or an addition to the rule, and it is apparent that the rule would be ineffective or unacceptable without incorporation of the change or addition.
(3) The comment causes the NRC staff to make a change (other than editorial) to the rule.
For procedural information and the regulatory analysis, see the direct final rule published in the Rules and Regulations section of this issue of the
Section 218(a) of the Nuclear Waste Policy Act (NWPA) of 1982, as amended, requires that “the Secretary [of the Department of Energy] shall establish a demonstration program, in cooperation with the private sector, for the dry storage of spent nuclear fuel at civilian nuclear power reactor sites, with the objective of establishing one or more technologies that the [Nuclear Regulatory] Commission may, by rule, approve for use at the sites of civilian nuclear power reactors without, to the maximum extent practicable, the need for additional site-specific approvals by the Commission.” Section 133 of the NWPA states, in part, that “[the Commission] shall, by rule, establish procedures for the licensing of any technology approved by the Commission under Section 219(a) [sic: 218(a)] for use at the site of any civilian nuclear power reactor.”
To implement this mandate, the Commission approved dry storage of spent nuclear fuel in NRC-approved casks under a general license by publishing a final rule which added a new subpart K in part 72 of title 10 of the
The Plain Writing Act of 2010 (Pub. L. 111-274) requires Federal agencies to write documents in a clear, concise, well-organized manner. The NRC has written this document to be consistent with the Plain Writing Act as well as the Presidential Memorandum, “Plain Language in Government Writing,” published June 10, 1998 (63 FR 31883). The NRC requests comment on the proposed rule with respect to clarity and effectiveness of the language used.
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
Administrative practice and procedure, Hazardous waste, Indians, Intergovernmental relations, Nuclear energy, Penalties, Radiation protection, Reporting and recordkeeping requirements, Security measures, Whistleblowing.
For the reasons set out in the preamble and under the authority of the Atomic Energy Act of 1954, as amended; the Energy Reorganization Act of 1974, as amended; the Nuclear Waste Policy Act of 1982, as amended; and 5 U.S.C. 552 and 553; the NRC is proposing to
Atomic Energy Act of 1954, secs. 51, 53, 57, 62, 63, 65, 69, 81, 161, 182, 183, 184, 186, 187, 189, 223, 234, 274 (42 U.S.C. 2071, 2073, 2077, 2092, 2093, 2095, 2099, 2111, 2201, 2210e, 2232, 2233, 2234, 2236, 2237, 2238, 2273, 2282, 2021); Energy Reorganization Act of 1974, secs. 201, 202, 206, 211 (42 U.S.C. 5841, 5842, 5846, 5851); National Environmental Policy Act of 1969 (42 U.S.C. 4332); Nuclear Waste Policy Act of 1982, secs. 117(a), 132, 133, 134, 135, 137, 141, 145(g), 148, 218(a) (42 U.S.C. 10137(a), 10152, 10153, 10154, 10155, 10157, 10161, 10165(g), 10168, 10198(a)); 44 U.S.C. 3504 note.
For the Nuclear Regulatory Commission.
Federal Aviation Administration (FAA), DOT.
Notice of proposed amended special conditions.
This action proposes amended special conditions for the Gulfstream Aerospace Corporation (Gulfstream) Model GVII-G500 airplane. This amendment changes an error in a reference to a special conditions number and adds one special condition. This airplane will have a novel or unusual design feature when compared to the state of technology envisioned in the airworthiness standards for transport-category airplanes. This design feature is airbag systems on multiple-place and single-place side-facing seats. The applicable airworthiness regulations do not contain adequate or appropriate safety standards for this design feature. These special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.
Send comments on or before November 21, 2018.
Send comments identified by Docket No. FAA-2017-0240 using any of the following methods:
•
•
•
•
Alan Sinclair, Airframe and Cabin Safety Section, AIR-675, Transport Standards Branch, Policy and Innovation Division, Aircraft Certification Service, Federal Aviation Administration, 2200 South 216th Street, Des Moines, Washington 98198; telephone and fax 206-231-3215.
We invite interested people to take part in this rulemaking by sending written comments, data, or views. The most helpful comments reference a specific portion of the proposed special conditions, explain the reason for any recommended change, and include supporting data.
We will consider all comments we receive by the closing date for comments. We may change these special conditions based on the comments we receive.
On March 29, 2012, Gulfstream Aerospace Corporation applied for a type certificate for their new Model GVII-G500 airplane. The Model GVII-G500 airplane will be a twin-engine, transport-category, business jet capable of accommodating up to 19 passengers. The Model GVII-G500 airplane will have a maximum takeoff weight of 76,850 lbs.
The FAA issued “final special conditions, request for comments” for airbag systems on multiple-place and single-place side-facing seats installed in Gulfstream Model GVII-G500 airplanes, on June 8, 2017. The special conditions were published in the
Under the provisions of title 14, Code of Federal Regulations (14 CFR) 21.17, Gulfstream must show that the Model GVII-G500 airplane meets the applicable provisions of 14 CFR part 25, as amended by amendments 25-1 through 25-129.
If the Administrator finds that the applicable airworthiness regulations (
Special conditions are initially applicable to the model for which they are issued. Should the type certificate for that model be amended later to include any other model that incorporates the same or similar novel or unusual design feature, the special conditions would also apply to the other model under § 21.101.
In addition to the applicable airworthiness regulations and special conditions, Model GVII-G500 airplanes must comply with the fuel-vent and exhaust-emission requirements of 14 CFR part 34, and the noise-certification requirements of 14 CFR part 36.
The FAA issues special conditions, as defined in 14 CFR 11.19, in accordance with § 11.38, and they become part of the type certification basis under § 21.17(a)(2).
The Model GVII-G500 airplane will incorporate the following novel or unusual design feature:
Airbag systems on multiple-place and single-place side-facing seats.
Side facing seats are considered a novel design for transport-category airplanes that include 14 CFR part 25, amendment 25-64, in their certification bases because this feature was not anticipated when those airworthiness standards were issued. Therefore, the existing regulations do not provide adequate or appropriate safety standards for occupants of side-facing seats. For the Model GVII-G500 airplane, FAA Special Conditions No. 25-618-SC, “Technical Criteria for Approving Side-Facing Seats,” provide special conditions to address the certification of single- and multiple-place side-facing seats. Those special conditions include condition 2(e), which requires the axial rotation of the upper leg (femur) to be limited to 35 degrees in either direction from the nominal seat position. To accommodate that requirement, Gulfstream has developed a new airbag system that will be installed close to the floor, and which is designed to limit the axial rotation of the occupant's upper legs.
This amendment changes, in the second paragraph of the Special Conditions section, an erroneous reference to Special Conditions No. 25-495-SC, which is here corrected to 25-618-SC, and adds special condition number 14 to the Special Conditions section. Special Condition 14 was unintentionally omitted from the previous issuance of these special conditions.
These proposed special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.
As discussed above, these special conditions are applicable to the Gulfstream Model GVII-G500 airplane. Should Gulfstream apply at a later date for a change to the type certificate to include another model incorporating the same novel or unusual design feature, these special conditions would apply to that model as well.
This action affects only certain novel or unusual design features on one model of airplane. It is not a rule of general applicability.
Aircraft, Aviation safety, Reporting and recordkeeping requirements.
The authority citation for these special conditions is as follows:
49 U.S.C. 106(f), 106(g), 40113, 44701, 44702, 44704.
Accordingly, the Federal Aviation Administration (FAA) proposes the following special conditions as part of the type certification basis for Gulfstream Aerospace Corporation Model GVII-G500 airplanes.
In addition to the requirements of §§ 25.562 and 25.785, and Special Conditions No. 25-618-SC, the following special conditions are part of the type certification basis for the Gulfstream Model GVII-G500 airplane with leg-flail airbags installed on side-facing seats.
1. For seats with a leg-flail airbag system, the system must deploy and provide protection under crash conditions where it is necessary to prevent serious injury. The means of protection must take into consideration a range of stature from a 2-year-old child to a 95th-percentile male. At some buttock popliteal length and effective seat-bottom depth, the lower legs will not be able to form a 90-degree angle relative to the upper leg; at this point, the lower leg flail would not occur. The leg-flail airbag system must provide a consistent approach to prevention of leg flail throughout that range of occupants whose lower legs can form a 90-degree angle relative to the upper legs when seated upright in the seat. Items that need to be considered include, but are not limited to, the range of occupants' popliteal height, the range of occupants' buttock popliteal length, the design of the seat effective height above the floor, and the effective depth of the seat-bottom cushion.
2. The leg-flail airbag system must provide adequate protection for each occupant regardless of the number of occupants of the seat assembly, considering that unoccupied seats may have an active leg-flail airbag system.
3. The leg-flail airbag system must not be susceptible to inadvertent deployment as a result of wear and tear, or inertial loads resulting from in-flight or ground maneuvers (including gusts and hard landings), and other operating and environmental conditions (vibrations, moisture, etc.) likely to occur in service.
4. Deployment of the leg-flail airbag system must not introduce injury mechanisms to the seated occupant, nor result in injuries that could impede rapid egress.
5. Inadvertent deployment of the leg-flail airbag system, during the most critical part of the flight, must either meet the requirement of § 25.1309(b), or not cause a hazard to the airplane or its occupants.
6. The leg-flail airbag system must not impede rapid egress of occupants from the airplane 10 seconds after airbag deployment.
7. The leg-flail airbag system must be protected from lightning and high-intensity radiated fields (HIRF). The threats to the airplane specified in existing regulations regarding lightning (§ 25.1316) and HIRF (§ 25.1317) are incorporated by reference for the purpose of measuring lightning and HIRF protection.
8. The leg-flail airbag system must function properly after loss of normal
9. The leg-flail airbag system must not release hazardous quantities of gas or particulate matter into the cabin.
10. The leg-flail airbag system installation must be protected from the effects of fire such that no hazard to occupants will result.
11. A means must be available to verify the integrity of the leg-flail airbag system's activation system prior to each flight, or the leg-flail airbag system's activation system must reliably operate between inspection intervals. The FAA considers that the loss of the leg-flail airbag system's deployment function alone (
12. The airbag inflatable material may not have an average burn rate of greater than 2.5 inches per minute when tested using the horizontal flammability test defined in part 25, appendix F, part I, paragraph (b)(5).
13. The leg-flail airbag system, once deployed, must not adversely affect the emergency-lighting system (
14. The leg flail system(s) must perform its intended function after impact from any other proximate assemblies (
Federal Aviation Administration (FAA), DOT.
Notice of document availability and request for comments.
This document announces the availability of the Airline Transport Pilot (ATP) and Type Rating for Airplane Airman Certification Standards (FAA-S-ACS-11) for public comment.
Send comments on or before December 21, 2018.
Send comments identified by docket number FAA-2018-0811 using any of the following methods:
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Larry West, Regulatory Support Division, Federal Aviation Administration, FAA Mike Monroney Aeronautical Center, P.O. Box 25082, Oklahoma City, OK 73125; telephone 405-954-4431; email:
Under 49 U.S.C. 44703(a), the Administrator is required to issue an airman certificate when the Administrator finds, after investigation, that an individual is qualified for, and physically able to perform the duties related to the position authorized by the certificate. Consistent with this authority, the Administrator establishes testing standards to ensure that inspectors and designated examiners conducting practical tests under the Administrator's authority determine that an applicant is qualified for and physically able to perform the duties related to the position authorized by the certificate or rating sought.
The FAA established the Aviation Rulemaking Advisory Committee (ARAC) to provide information, advice, and recommendations on aviation related issues that could result in rulemaking to the Administrator, through the Associate Administrator of Aviation Safety. On December 19, 2013, ARAC accepted the FAA's assignment of a new task to establish an Airman Certification Standards Working Group (ACS WG) to assist in the development of standards, training guidance, test management, and reference materials for airman certification testing. The FAA announced the ARAC's acceptance of this task through a
On June 21, 2018, the ARAC met and approved the Interim Final Report of the ACS WG. The Interim Final Report contained a recommendation for the Airline Transport Pilot and Type Rating for Airplane (ATP/Type Rating) ACS. The FAA received that recommendation from ARAC on June 22, 2018. The FAA has reviewed the draft ATP/Type Rating ACS, made some changes based on internal feedback, and is now seeking comment from the public. A copy of the document has been placed in the docket for this action. The FAA will review and consider all comments received and make any necessary changes prior to issuing the final version of the ATP/Type Rating ACS. The final version of the ATP/Type Rating ACS will be
The FAA invites interested persons to join in this notice and comment process by filing written comments, data, or views. 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. More information on submitting comments can be found in the
The FAA will review all comments it receives on or before the closing date for the comment period. The FAA will consider comments submitted after the comment period has closed if it is possible to do so without incurring expense or delay. The FAA may make changes based on the comments it receives.
Food and Drug Administration, HHS.
Notification of availability.
The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a draft guidance for industry entitled “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption.” The draft guidance, when finalized, will provide FDA's current thinking and recommendations to help covered farms comply with the final regulation entitled “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption” (Produce Safety Rule), which established science-based minimum standards for the safe growing, harvesting, packing, and holding of produce grown for human consumption.
Submit either electronic or written comments on the draft guidance by April 22, 2019 to ensure that the Agency considers your comment on the 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)).
Submit written requests for single copies of the draft guidance to the Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740. Send two self-addressed adhesive labels to assist that office in processing your request. See the
Samir Assar, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1636.
We are announcing the availability of a draft guidance for industry entitled “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption.” We are issuing the draft guidance consistent with our good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternate approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866.
We intend to conduct four public meetings in diverse regions of the United States to discuss the draft guidance, and we will provide details about these public meetings in a notice published in the
The Produce Safety Rule (80 FR 74353) established science-based minimum standards for the safe growing, harvesting, packing, and holding of produce grown for human consumption. The rule sets forth procedures, processes, and practices that minimize the risk of serious adverse health consequences or death, including those reasonably necessary to prevent the introduction of known or reasonably foreseeable biological hazards into or onto produce and to provide reasonable assurances that the produce is not adulterated on account of such hazards. Requirements of the rule focus on major routes of contamination, including health and hygiene; biological soil amendments of animal origin; domesticated and wild animals; and equipment, tools, and buildings.
This draft guidance provides recommendations, examples, and information related to compliance and implementation of the following subparts of the Produce Safety Rule:
Subpart A—General Provisions
Subpart C—Personnel Qualifications and Training
Subpart D—Health and Hygiene
Subpart F—Biological Soil Amendments of Animal Origin and Human Waste
Subpart I—Domesticated and Wild Animals
Subpart K—Growing, Harvesting, Packing, and Holding Activities
Subpart L—Equipment, Tools, Buildings, and Sanitation
Subpart O—Records
Subpart P—Variances
This draft guidance is based on FDA's current thinking and we believe that additional information would assist us in developing the final guidance. While we invite comments on all aspects of the draft guidance, we seek specific comments, information, and data on the following:
• When acquiring equipment and tools, how do you engage with equipment and tool suppliers about the size, design, and construction of your buildings so that they can accommodate the equipment and tools?
• What information or data can you provide about cleaning, sanitizing, and maintenance practices and procedures for equipment and tools that have wood, foam, or other porous or absorbent materials?
• What data or information can you provide about factors or conditions that would affect the likelihood of contamination of covered produce by animals? Such factors include, for example, historical information and conditions on or near farms that influence animal habitats.
This draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 112 have been approved under OMB control number 0910-0816.
Persons with access to the internet may obtain the draft guidance at either
Food and Drug Administration, HHS.
Notification of availability.
The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a draft guidance for industry entitled “Guide to Minimize Food Safety Hazards of Fresh-cut Produce.” The draft guidance, when finalized, will supersede a previous guidance, entitled “Guide to Minimize Microbial Food Safety Hazards of Fresh-cut Fruits and Vegetables,” that we issued in 2008. The draft guidance is intended to explain our current thinking on how to comply with recently modernized requirements for current good manufacturing practice (CGMP) and with new requirements for hazard analysis and risk-based preventive controls under our regulation entitled “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food” during the production of fresh-cut produce.
Submit either electronic or written comments on the draft guidance by April 22, 2019 to ensure that the Agency considers your comment on the 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)).
Submit written requests for single copies of the draft guidance to the Office of Food Safety, Division of Produce Safety, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740. Send two self-addressed adhesive labels to assist that office in processing your request. See the
Insook Son, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1648.
We are announcing the availability of a draft guidance for industry entitled “Guide to Minimize Food Safety Hazards of Fresh-cut Produce.” We are issuing the draft guidance consistent with our good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternate approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866.
The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353) enables FDA to better protect public health by helping to ensure the safety and security of the food supply. FSMA enables FDA to focus more on preventing food safety problems rather than relying primarily on reacting to problems after they occur. FSMA recognizes the important role industry plays in ensuring the safety of the food supply, including the adoption of modern systems of preventive controls in food production. Section 103 of FSMA amended the Federal Food, Drug, and Cosmetic Act (FD&C Act), by adding section 418 (21 U.S.C. 350g) with requirements for hazard analysis and risk-based preventive controls for establishments that are required to register as food facilities under our regulations in 21 CFR part 1, subpart H, in accordance with section 415 of the FD&C Act (21 U.S.C. 350d).
In 2008, we issued a guidance for industry entitled “Guide to Minimize Microbial Food Safety Hazards of Fresh-cut Fruits and Vegetables.” Fresh-cut fruits and vegetables mean any fresh fruit or vegetable or combination thereof that has been physically altered from its whole state after being harvested from the field (
In the
This draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of
Persons with access to the internet may obtain the draft guidance at either
Coast Guard, DHS.
Notice of proposed rulemaking.
The Coast Guard proposes to establish a temporary safety zone on a portion of the Delaware River in Camden, NJ. This action is necessary to protect the surrounding public and vessels on these navigable waters adjacent to the Battleship New Jersey Museum and Memorial, Camden, NJ, during a fireworks display on November 14, 2018. This proposed rulemaking would prohibit persons and vessels from entering, transiting, or remaining within the safety zone unless authorized by the Captain of the Port Delaware Bay or a designated representative. We invite your comments on this proposed rulemaking.
Comments and related material must be received by the Coast Guard on or before November 6, 2018.
You may submit comments identified by docket number USCG-2018-0948 using the Federal eRulemaking Portal at
If you have questions about this proposed rulemaking, call or email Petty Officer Thomas Welker, U.S. Coast Guard, Sector Delaware Bay, Waterways Management Division; telephone 215-271-4814, email
On September 14, 2018, Rexel, Inc notified the Coast Guard that it will be conducting a fireworks display from 8:35 p.m. to 8:55 p.m. on November 14, 2018. The fireworks are to be launched from a barge in the Delaware River adjacent to the Battleship New Jersey Museum and Memorial, Camden, NJ. Hazards from fireworks displays include accidental discharge of fireworks, dangerous projectiles, and falling hot embers or other debris. The Captain of the Port Delaware Bay (COTP) has determined that potential hazards associated with the fireworks to be used in this display would be a safety concern for anyone within a 600-foot radius of the barge.
The purpose of this rulemaking is to ensure the safety of vessels and the navigable waters within a 600-foot radius of the fireworks barge before, during, and after the scheduled event. The Coast Guard proposes this rulemaking under authority in 33 U.S.C. 1231.
The COTP is proposing to establish a safety zone from approximately 8:15 p.m. through 9:15 p.m. on November 14, 2018. The safety zone would cover all navigable waters within 600 feet of a fireworks barge in the Delaware River adjacent to the Battleship New Jersey Museum and Memorial, Camden, NJ. The barge will be anchored in approximate position 39°56′20″ N Latitude, 075°08′08″ W Longitude. The duration of the zone is intended to ensure the safety of vessels and these navigable waters before, during, and after the scheduled 8:35 p.m. to 8:55 p.m. fireworks display. No vessel or person would be permitted to enter, transit, or remain within the safety zone without obtaining permission from the COTP or a designated representative. The regulatory text we are proposing appears at the end of this document.
We developed this proposed 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 NPRM has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, the NPRM 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-day of the safety zone. Vessel traffic would be able to safely transit around this safety zone which would impact a small designated area of the Delaware River for one hour during the evening when vessel traffic is normally low. Moreover, the Coast Guard would issue a Broadcast Notice to Mariners via VHF-FM marine channel 16 about the zone, and the rule would allow vessels to seek permission to enter the 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 proposed rule would not have a significant economic impact on a substantial number of small entities.
While some owners or operators of vessels intending to transit the safety zone may be small entities, for the reasons stated in section IV.A above, this proposed rule would not have a significant economic impact on any vessel owner or operator.
If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this rule would have a significant economic impact on it, please submit a comment (see
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this proposed rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the
This proposed rule would 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 proposed 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 proposed rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it would not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. If you believe this proposed rule has implications for federalism or Indian tribes, please contact the person listed in the
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this proposed rule would not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.
We have analyzed this proposed 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 made a preliminary determination 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 proposed rule involves a safety zone lasting one hour that would prohibit entry within 600 feet of a fireworks barge. Normally such actions are 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 preliminary 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
We view public participation as essential to effective rulemaking, and will consider all comments and material received during the comment period. Your comment can help shape the outcome of this rulemaking. If you submit a comment, please include the docket number for this rulemaking, indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation.
We encourage you to submit comments through the Federal eRulemaking Portal at
We accept anonymous comments. All comments received will be posted without change to
Documents mentioned in this NPRM as being available in the docket, and all public comments, will be in our online docket at
Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways.
For the reasons discussed in the preamble, the Coast Guard proposes to amend 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)
(i) You may not enter the safety zone described in paragraph (a) of this section unless authorized by the COTP or the COTP's designated representative; and
(ii) All persons and vessels in the safety zone must comply with all lawful orders or directions given to them by the COTP or the COTP's designated representative.
(2) To request permission to enter the safety zone, contact the COTP or the COTP's representative on marine band radio VHF-FM channel 16 (156.8 MHz) or 215-271-4807.
(3) No vessel may take on bunkers or conduct lightering operations within the safety zone during the enforcement period.
(4) This section applies to all vessels except those engaged in law enforcement, aids to navigation servicing, and emergency response operations.
(d)
(e)
Environmental Protection Agency (EPA).
Proposed rule.
The Environmental Protection Agency (EPA) proposes to determine that the West Silver Valley, Idaho nonattainment area has clean data for the 2012 annual fine particulate matter (PM
Written comments must be received on or before November 21, 2018.
Submit your comments, identified by Docket ID No. EPA-R10-OAR-2017-0170, at
Justin Spenillo, at 206-553-6125, or
Throughout this document, wherever “we”, “us” or “our” are used, it is intended to refer to the EPA.
On December 14, 2012, the Environmental Protection Agency (EPA) promulgated a revised primary annual PM
On March 26, 2018, the EPA issued a finding of failure to submit under section 110(k) of the CAA finding that several states, including Idaho, failed to submit specific moderate area SIP elements for the 2012 annual PM
On August 24, 2016, the EPA issued the Fine Particulate Matter National Ambient Air Quality Standards: State Implementation Plan Requirements (“PM
Over the past 2 decades, the EPA has consistently applied its “Clean Data Policy” interpretation to attainment
As provided in 40 CFR 51.1015, so long as an area continues to meet the standard, finalization of a CDD suspends the requirements for a nonattainment area to submit an attainment demonstration, associated RACM and RACT, an RFP plan, quantitative milestones, contingency measures, and any other SIP requirements related to the attainment of the 2012 annual PM
By extension, the requirement to submit a motor vehicle emissions budget (MVEB) for the attainment year for the purposes of transportation conformity is also suspended. A MVEB is that portion of the total allowable emissions defined in the submitted or approved control strategy implementation plan revision or maintenance plan for a certain date for the purpose of meeting RFP milestones or demonstrating attainment or maintenance of the NAAQS, for any criteria pollutant or its precursors, allocated to highway and transit vehicle use and emissions. For the purposes of the transportation conformity regulations, the control strategy implementation plan revision is the implementation plan which contains specific strategies for controlling the emissions of and reducing ambient levels of pollutants in order to satisfy CAA requirements for demonstrations of RFP and attainment. Given that MVEBs are required to support the RFP and attainment demonstration requirements in the attainment plan, suspension of the RFP and attainment demonstration requirements through a CDD, also suspends the requirement to submit MVEBs for the attainment and RFP years. The suspension of planning requirements pursuant to 40 CFR 51.1015, does not preclude the state from submitting suspended elements of its moderate area attainment plan for EPA approval for the purposes of strengthening the state's SIP.
The suspension of the obligation to submit such requirements applies regardless of when the plan submissions are due. A clean data determination is not equivalent to a redesignation, and the state must still meet the statutory requirements for redesignation in order to be redesignated to attainment.
In accordance with 40 CFR 51.1015(a)(1) and (2), the CDD suspends the aforementioned SIP obligations until such time as the area is redesignated to attainment, after which such requirements are permanently discharged; or the EPA determines that the area has re-violated the PM
Under the EPA regulations at 40 CFR 50.18 and part 50, appendix N, the 2012 annual PM
Consistent with the requirements contained in 40 CFR part 58, the EPA has reviewed the PM
The CAA allows for the exclusion of air quality monitoring data from design
On August 24, 2018, the EPA concurred with the IDEQ's request to exclude event-influenced data listed in Table 2. As such, the event-influenced data have been removed from the data set used for regulatory purposes. For this proposed action, the EPA relies on the calculated values that exclude the event-influenced data (see Table 1, above). The EPA now proposes to take final regulatory action on the IDEQ's request to exclude PM
Pursuant to the Clean Data Policy codified at 40 CFR 51.1015(a), the EPA proposes to determine that based on 3-years of certified, valid monitoring data between 2015 and 2017, the WSV NAA has attained the 2012 annual PM
This proposed determination of attainment does not constitute a redesignation to attainment. The WSV NAA will remain designated nonattainment for the 2012 annual PM
This action proposes to exclude certain air quality monitoring data from design value calculations and suspend certain federal requirements, and thus would not impose additional requirements beyond those imposed by state law. For these reasons, this proposed action:
• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
• is not an Executive Order 13771 (82 FR 9339, February 2, 2017) regulatory action because SIP approvals are exempted under Executive Order 12866;
• does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because it does not involve technical standards; and
• does not provide the EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
In addition, this proposed action does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because the SIP obligations discussed herein do not apply to Indian tribes and, thus, this proposed action will not impose substantial direct costs on tribal governments or preempt tribal law.
Environmental protection, Air pollution control, Incorporation by reference, Particulate matter, Reporting and recordkeeping requirements.
42 U.S.C. 7401
Environmental Protection Agency and National Highway Traffic Safety Administration.
Proposed rule; correction.
This document corrects information in the proposed rule published in the August 24, 2018 issue of the
Comments for the proposed rule must be received on or before October 26, 2018.
In the proposed rule beginning at 83 FR 42986, in the issue of August 24, 2018, make the following corrections:
On page 43480, replace the existing Table XII-2 with the following table:
On page 43489, third column, remove the first instance of instruction 16 and in the second, in paragraph (a)(4)(ii) correct “8,877” to read “8,887.”
On page 43494, replace existing Table 1 to Paragraph (c)(2)(i)(A) with the following table:
On Page 43495 replace Table 1 to Paragraph (c)(2)(i)(B) with the following table:
On Page 43496 replace the table currently titled “Table 1 to Table 1 to Paragraph (c)(2)(i)(C)” with the following table header and table:
On Page 43497 replace the table currently titled “Table 1 to Table 1 to Paragraph (c)(3)(i)(A)” with the following table header and table:
On Page 43498 replace the table currently titled “Table 1 to Table 1 to Paragraph (c)(3)(i)(B)” with the following table header and table:
On Page 43499 replace the table currently titled “Table 1 to Table 1 to Paragraph (c)(3)(i)(D)” with the following table header and table:
The Department of Agriculture has submitted the following information collection requirement(s) to OMB for review and clearance under the Paperwork Reduction Act of 1995, Public Law 104-13. Comments are requested regarding (1) whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) the accuracy of the agency's estimate of burden 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 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.
Comments regarding this information collection received by November 21, 2018 will be considered. Written comments should be addressed to: Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), New Executive Office Building, 725 17th Street NW, Washington, DC 20502. Commenters are encouraged to submit their comments to OMB via email to:
An agency may not conduct or sponsor a collection of information unless the collection of information displays a currently valid OMB control number and the agency informs potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number.
U.S. Codex Office, USDA.
Notice of public meeting and request for comments.
The U.S Codex Office is sponsoring a public meeting on December 5, 2018. The objective of the public meeting is to provide information and receive public comments on agenda items and draft United States (U.S.) positions to be discussed at the 4th Session of the Codex Committee on Spices and Culinary Herbs (CCSCH) of the Codex Alimentarius Commission, in Thiruvananthapuram, India, January 21-25, 2019. The U.S. Manager for Codex Alimentarius and the Under Secretary, Office of Trade and Foreign Agricultural Affairs, recognize the importance of providing interested parties the opportunity to obtain background information on the 4th Session of the CCSCH and to address items on the agenda.
The public meeting is scheduled for Wednesday, December 5, 2018 from 2 p.m. to 4 p.m.
The public meeting will take place at the United States Department of Agriculture (USDA), Jamie L. Whitten Building, 1400 Independence Avenue SW, Room 107-A, Washington, DC 20250. Documents related to the 4th Session of the CCSCH will be accessible via the internet at the following address:
Dorian LaFond, U.S. Delegate to the 4th Session of the CCSCH invites U.S. interested parties to submit their comments electronically to the following email address:
The participant code will be posted on the following web page:
Codex was established in 1963 by two United Nations organizations, the Food and Agriculture Organization and the World Health Organization. Through adoption of food standards, codes of practice, and other guidelines developed by its committees, and by promoting their adoption and implementation by governments, Codex seeks to protect the health of consumers and ensure fair practices in the food trade.
The CCSCH is responsible for elaborating worldwide standards for spices and culinary herbs in their dried and dehydrated state in whole, ground, and cracked or crushed form and consulting, as necessary, with other international organizations in the standards development process to avoid duplication.
The CCSCH is hosted by India. The U.S. attends CCSCH as a member country of Codex.
The following items on the Agenda for the 4th Session of the CCSCH will be discussed during the public meeting:
At the December 6, 2018, public meeting, draft U.S. positions on the agenda items will be described and discussed, and attendees will have the opportunity to pose questions and offer comments. Written comments may be offered at the meeting or sent to Dorian LaFond, U.S. Delegate for the 4th Session of the CCSCH (see
Public awareness of all segments of rulemaking and policy development is important. Consequently, the U.S. Codex Office will announce this
No agency, officer, or employee of the USDA shall, on the grounds of race, color, national origin, religion, sex, gender identity, sexual orientation, disability, age, marital status, family/parental status, income derived from a public assistance program, or political beliefs, exclude from participation in, deny the benefits of, or subject to discrimination any person in the United States under any program or activity conducted by the USDA.
To file a complaint of discrimination, complete the USDA Program Discrimination Complaint Form, which may be accessed online at
Persons with disabilities who require alternative means for communication (Braille, large print, audiotape, etc.) should contact USDA's TARGET Center at (202) 720-2600 (voice and TDD).
National Institute of Food and Agriculture, USDA.
Notice and solicitation for nominations.
The National Institute of Food and Agriculture (NIFA) is soliciting nominations of veterinary service shortage situations for the Veterinary Medicine Loan Repayment Program (VMLRP) for fiscal year (FY) 2019, as authorized under the National Veterinary Medical Services Act (NVMSA). This notice initiates the nomination period and prescribes the procedures and criteria to be used by eligible nominating officials (State, Insular Area, DC and Federal Lands) to nominate veterinary shortage situations. Each year all eligible nominating officials may submit nominations, up to the maximum indicated for each entity in this notice. NIFA is conducting this solicitation of veterinary shortage situation nominations under an approved information collection (OMB Control Number 0524-0050).
Shortage situation nominations must be submitted not later than 30 days after the publication of this notice.
Submissions must be made by clicking the submit button on the Veterinarian Shortage Situation nomination form provided in the
This form is sent as a data file directly to the Veterinary Medicine Loan Repayment Program; National Institute of Food and Agriculture; U.S. Department of Agriculture.
Michelle Colby; National Program Leader; National Institute of Food and Agriculture; U.S. Department of Agriculture; STOP 2240 1400 Independence Avenue SW, Washington, DC 20250-2220; Voice: 202-401-4202; Fax: 833-208-8205; Email:
Food supply veterinary medicine embraces a broad array of veterinary professional activities, specialties and responsibilities, and is defined as all aspects of veterinary medicine's involvement in food supply systems, from traditional agricultural production to consumption. A series of studies and reports
Two programs, born out of this concern, aim to mitigate the maldistribution of the veterinary workforce: The Veterinary Medicine Loan Repayment Program (VMLRP) and Veterinary Services Grant Program (VSGP), both administered by USDA-NIFA. VMLRP addresses increasing veterinary school debt by offering veterinary school debt payments in exchange for service in shortage situations, while VSGP addresses other factors contributing to the maldistribution of veterinarians serving the agricultural sector.
Specifically, the VSGP promotes availability and access to (1) specialized education and training which will enable veterinarians and veterinary technicians to provide services in designated veterinarian shortage situations, and (2) practice-enhancing equipment and personnel resources to enable veterinary practices to expand or improve access to veterinary services.
In accordance with the Office of Management and Budget (OMB) regulations (5 CFR part 1320) that implement the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the information collection and recordkeeping requirements imposed by the implementation of these guidelines have been approved by OMB Control Number 0524-0050.
In January 2003, the National Veterinary Medical Service Act (NVMSA) was passed into law adding section 1415A to the National Agricultural Research, Extension, and Teaching Policy Act of 1997 (NARETPA). This law established a new Veterinary Medicine Loan Repayment Program (7 U.S.C. 3151a) authorizing the Secretary of Agriculture to carry out a program of entering into agreements with veterinarians under which they agree to provide veterinary services in veterinarian shortage situations in return for repayment of qualified educational loans. In FY 2010, NIFA announced the first funding opportunity for the VMLRP.
Section 7104 of the 2014 Farm Bill (Pub. L. 113-79) added section 1415B to NARETPA, as amended, (7 U.S.C. 3151b) to establish the Veterinary Services Grant Program (VSGP). This amendment authorizes the Secretary of Agriculture to make competitive grants to qualified entities and individual veterinarians that carry out programs in veterinarian shortage situations and for the purpose of developing, implementing, and sustaining veterinary services. Funding for the VSGP was first appropriated in FY 2016 through the Consolidated Appropriations Act, 2016 (Pub. L. 114-113).
Pursuant to the requirements enacted in the NVMSA of 2004 (as revised), and the implementing regulation for this Act, Part 3431 Subpart A of the VMLRP Final Rule [75 FR 20239-20248], NIFA hereby implements guidelines for eligible nominating officials to nominate veterinary shortage situations for the FY 2018 program cycle.
Section 1415A of NARETPA, as amended and revised by Section 7105 of the Food, Conservation and Energy Act, directs determination of veterinarian shortage situations for the VMLRP to consider (1) geographical areas that the Secretary determines have a shortage of veterinarians; and (2) areas of veterinary practice that the Secretary determines have a shortage of veterinarians, such as food animal medicine, public health, epidemiology, and food safety. This section also added that priority should be given to agreements with veterinarians for the practice of food animal medicine in veterinarian shortage situations.
While the NVMSA (as amended) specifies priority be given to food animal medicine shortage situations, and that consideration also be given to specialty areas such as public health, epidemiology and food safety, the Act does not identify any areas of veterinary practice as ineligible. Accordingly, all nominated veterinary shortage situations will be considered eligible for submission.
A subset of the shortages designated for VMLRP applicants is also available to satisfy requirements, as applicable, for VSGP applicants. In addition, a shortage situation under the VSGP must also be designated rural as defined in section 343(a) of the Consolidated Farm and Rural Development Act (7 U.S.C. 1991(a)).
Nominations describing either public or private practice veterinary shortage situations are eligible for submission.
The only authorized respondent on behalf of each State is the chief State Animal Health Official (SAHO), as duly authorized by the Governor or the Governor's designee in each State. The only authorized respondent on behalf of the Federal Government is the Chief Federal Animal Health Officer (Deputy Administrator of Veterinary Services, the Animal and Plant Health Inspection Service or designee), as duly authorized by the Secretary of Agriculture. The eligible nominating official must submit nominations using the instructions provided in section A.4, FY 2018 Shortage Situation Nomination Process. NIFA strongly encourages the nominating officials to involve leading health animal experts in the State in the identification and prioritization of shortage situation nominations.
NIFA will accept the number of nominations equivalent to the maximum number of designated shortage areas for each State. For historical background and more information on the rationale for capping nominations and State allocation method, visit
The maximum number of nominations (and potential designations) is based on data from the 2012 Agricultural Census conducted by the USDA National Agricultural Statistics Service (NASS). Awards from previous years have no bearing on a State's maximum number of allowable shortage nomination submissions or designations in any given year, or number of nominations or designations allowed for subsequent years. NIFA reserves the right in the future to proportionally adjust the maximum number of designated shortage situations per State to ensure a balance between available funds and the requirement to ensure that priority is given to mitigating veterinary shortages corresponding to situations of greatest need. Nomination Allocation tables for FY 2019 are available under the VMLRP Shortage Situations section of the VMLRP website at
Table I lists the maximum nomination allocations by State. Table II lists “Special Consideration Areas” which include any State or Insular Area not reporting data to NASS, reporting less than $1,000,000 in annual Livestock and Livestock Products Total Sales ($), and/or possessing less than 500,000 acres. One nomination is allocated to any State or Insular Area classified as a Special Consideration Area.
Table III shows the values and quartile ranks of States for two variables broadly correlated with demand for food supply veterinary services: “Livestock and Livestock Products Total Sales ($)” (LPTS) and “Land Area (acres)” (LA). The maximum number of NIFA-designated shortage situations per State is based on the sum of quartile rankings for LPTS and LA for each State and can be found in Table IV.
While Federal Lands are widely dispersed within States and Insular Areas across the country, they constitute a composite total land area over twice the size of Alaska. If the 200-mile limit for U.S. coastal waters and associated fishery areas are included, Federal Land total acreage would exceed 1 billion. Both State and Federal Animal Health officials have responsibilities for matters relating to terrestrial and aquatic food animal health on Federal Lands. Interaction between wildlife and domestic livestock, such as sheep and cattle, is particularly common in the plains States where significant portions of Federal lands are leased for grazing. Therefore, both SAHOs and the Chief Federal Animal Health Officer (Deputy Administrator of Veterinary Services, the Animal and Plant Health Inspection Service or designee) may submit nominations to address shortage situations on or related to Federal Lands. Nominations related to Federal Lands submitted by SAHOs will count towards the maximum number of nominations for that individual state.
NIFA emphasizes that the shortage nomination allocation is set to broadly balance the number of designated shortage situations across States prior to the nomination and award phases of the VMLRP and VSGP. Awards will be made based strictly on the peer review panel's assessment according to each program's review criteria; thus no State will be given a preference for placement of awardees. Additionally, each designated shortage situation will be limited to one award per program.
For the FY 2019 program cycle, all eligible nominating officials submitting may: (1) Request to retain designated status for any shortage situation successfully designated in FY 2018 and/or (2) submit new nominations. Any shortage from FY 2018 not retained or submitted as a new nomination will not be considered a shortage situation in FY 2019. The total number of new nominations plus designated nominations retained (carried over) may not exceed the maximum number of nominations each eligible nominating official is permitted.
The following process is the mechanism for retaining a designated nomination: Each nominating official should review the map of VMLRP designated shortage situations for FY 2018 (
Both new and retained nominations must be submitted on the Veterinary Shortage Situation Nomination form provided in the VMLRP Shortage Situations section at
Nominations retained (carried over) will be designated without review unless major changes in content are identified during administrative processing or the shortage has been retained for three years. Major changes in content or shortages already retained for three consecutive years will be treated as new submissions and undergo merit review.
Submissions must be made by clicking the submit button on the Veterinarian Shortage Situation nomination form provided in the VMLRP Shortage Situations section at
Each shortage situation is approved for one program year cycle only. However, any previously approved shortage situation not filled in a given program year may be resubmitted as a retained (carry-over) nomination. Retained (carry-over) shortage nominations (without any revisions) will be automatically approved for up to three years before requiring another merit review. By resubmitting a carry-over nomination, the nominating official is affirming that in his or her professional judgment the original case
For the purpose of implementing the solicitation for veterinary shortage situations, the definitions provided in 7 CFR part 3431 are applicable.
The VMLRP Shortage Nomination Form must be used to nominate veterinarian shortage situations. Once designated as a shortage situation, VMLRP applicants will use the information to select shortage situations they are willing and qualified to fill, and to guide the preparation of their applications. NIFA will use the information to assess contractual compliance of awardees. The form is available in the VMLRP Shortage Situations section at
NIFA will convene a panel of food supply veterinary medicine experts from Federal and/or State agencies, and an institution receiving Animal Health and Disease Research Program funds under section 1433 of NARETPA, to review the nominations and make recommendations to the NIFA Program Manager. NIFA will review the panel's recommendations and designate the VMLRP shortage situations. The list of approved shortage situations will be made available on the VMLRP website at
Criteria used by the shortage situation nomination review panel and NIFA for certifying a veterinary shortage situation will be consistent with the information requested in the shortage situations nomination form. NIFA understands the process for defining the risk landscape associated veterinary service shortages within a State may require consideration of many qualitative and quantitative factors. In addition, each shortage situation will be characterized by a different array of subjective and objective supportive information that must be developed into a cogent case identifying, characterizing, and justifying a given geographic or disciplinary area as deficient in certain types of veterinary capacity or service. To accommodate the uniqueness of each shortage situation, the nomination form provides opportunities to present a case using both supportive metrics and narrative explanations to define and explain the proposed need.
While NIFA anticipates some arguments made in support of a given shortage situation will be qualitative, respondents are encouraged to present verifiable quantitative and qualitative evidentiary information wherever possible. Absence of quantitative data such as animal and veterinarian census data for the proposed shortage area(s) may lead the panel to recommend disapproval of the shortage nomination.
The maximum point value that panelists may award for each element is as follows:
An additional 20 points will be used to evaluate overall merit/quality of the case made for each nomination.
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 that the Michigan Advisory Committee (Committee) will hold a meeting on Wednesday November 14, 2018, at 12 p.m. EST for the purpose discussing next steps in their study of voting rights in the state.
The meeting will be held on Wednesday November 14, 2018, at 12 p.m. EST
Dial: 877-260-1479, Conference ID: 2679533.
Melissa Wojnaroski, DFO, at
Members of the public can listen to the discussion. This meeting is available to the public through the above toll-free call-in number. Any interested member of the public may call this number and listen to the meeting. An open comment period will be provided to allow members of the public to make a statement as time allows. The conference call operator will ask callers to identify themselves, the organization they are affiliated with (if any), and an email address prior to placing callers into the conference room. Callers can expect to incur regular charges for calls they initiate over wireless lines, according to their wireless plan. 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 also entitled to submit written comments; the comments must be received in the regional office within 30 days following the meeting. Written comments may be mailed to the Regional Programs Unit Office, U.S. Commission on Civil Rights, 230 S. Dearborn St., Suite 2120, Chicago, IL 60604. They may also be faxed to the Commission at (312) 353-8324, or emailed to Carolyn Allen at
Records generated from this meeting may be inspected and reproduced at the
Commission on Civil Rights.
Announcement of monthly planning 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 District of Columbia Advisory Committee to the Commission will convene by conference call, at 12:00 p.m. (EST) Thursday, November 1, 2018. The purpose of the planning meeting is to continue project planning for a future briefing meeting on the Committee's civil rights project, which will examine the treatment of homeless persons that get swept up in the DC criminal justice system, including a review of the DC Mental Health Court.
Thursday, November 1, 2018 at 12:00 p.m. (EST).
Ivy L. Davis, at
Interested members of the public may listen to the discussion by calling the following toll-free conference call number: 1-855-719-5012 and conference call ID: 3606878. Please be advised that before placing them into the conference call, the conference call operator may ask callers to provide their names, their organizational affiliations (if any), and email addresses (so that callers may be notified of future meetings). 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 herein.
Persons with hearing impairments may also follow the discussion by first calling the Federal Relay Service at 1-800-877-8339 and providing the operator with the toll-free conference call number: 1-855-719-5012 and conference call ID: 3606878.
Members of the public are entitled to submit written comments. The comments must be received in the regional office by Monday, December 3, 2018. Comments may be mailed to the Eastern Regional Office, U.S. Commission on Civil Rights, 1331 Pennsylvania Avenue, Suite 1150, Washington, DC 20425 or emailed to 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 a planning meeting of the Rhode Island State Advisory Committee to the Commission will convene by conference call, on Tuesday, November 13, 2018 at 11 a.m. (EST). The purpose of the meeting is to vote on the voting rights report and continue planning.
Tuesday, November 13, 2018, at 11 a.m. (EST).
Evelyn Bohor, at
Interested members of the public may listen to the discussion by calling the following toll-free conference call number: 1-877-260-1479 and conference call ID: 2287314. Please be advised that before placing them into the conference call, the conference call operator may ask callers to provide their names, their organizational affiliations (if any), and email addresses (so that callers may be notified of future meetings). 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 herein.
Persons with hearing impairments may also follow the discussion by first calling the Federal Relay Service at 1-800-877-8339 and providing the operator with the toll-free conference call number:1-877-260-1479 and conference call ID: 2287314.
Members of the public are invited to submit written comments; the comments must be received in the regional office approximately 30 days after each scheduled meeting. Written comments may be mailed to the Eastern Regional Office, U.S. Commission on Civil Rights, 1331 Pennsylvania Avenue, Suite 1150, Washington, DC 20425, or emailed to Evelyn Bohor at
Records and documents discussed during the meeting will be available for public viewing as they become available at
An application has been submitted to the Foreign-Trade Zones Board (the Board) by the Metroplex International Trade Development Corporation, grantee of FTZ 168, requesting subzone status for the facility of Schumacher Electric Corporation located in Fort Worth, Texas. The application was submitted pursuant to the provisions of the Foreign-Trade Zones Act, as amended (19 U.S.C. 81a-81u), and the regulations of the Board (15 CFR part 400). It was formally docketed on October 17, 2018.
The proposed subzone (24.41 acres) is located at 14200 FAA Boulevard in Fort Worth. No authorization for production activity has been requested at this time. The proposed subzone would be subject to the existing activation limit of FTZ 168.
In accordance with the Board's regulations, Camille Evans of the FTZ Staff is designated examiner to review the application and make recommendations to the Executive Secretary.
Public comment is invited from interested parties. Submissions shall be addressed to the Board's Executive Secretary at the address below. The closing period for their receipt is December 3, 2018. Rebuttal comments in response to material submitted during the foregoing period may be submitted during the subsequent 15-day period to December 17, 2018.
A copy of the application will be available for public inspection at the Office of the Executive Secretary, Foreign-Trade Zones Board, Room 21013, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230-0002, and in the “Reading Room” section of the Board's website, which is accessible via
For further information, contact Camille Evans at
This is a decision pursuant to Section 6(c) of the Educational, Scientific, and Cultural Materials Importation Act of 1966 (Pub. L. 89-651, as amended by Pub. L. 106-36; 80 Stat. 897; 15 CFR part 301). Related records can be viewed between 8:30 a.m. and 5:00 p.m. in Room 3720, U.S. Department of Commerce, 14th and Constitution Ave. NW, Washington, DC.
Docket Number: 17-019. Applicant: University of California, Berkeley, Berkeley, CA 94720. Instrument: High Field Cryogen-Free Measurement System (CFMS) for Precision Measurement of Physical Properties. Manufacturer: Cryogenic US, LLC., United Kingdom. Intended Use: See notice at 83 FR 45104, September 5, 2018. Comments: None received. Decision: Approved. We know of no instruments of equivalent scientific value to the foreign instruments described below, for such purposes as this is intended to be used, that was being manufactured in the United States at the time of order. Reasons: The instrument will be used to study thin films of metal-oxides for advanced oxide-based electronic devices, magnetic and electrical properties of oxide materials and devices at low temperatures and/or high magnetic fields. Angle dependent magnetoelectric properties of the devices will be explored on multiple axes. The investigations done with this instrument will lead to advancement of understanding of the properties of metal-oxide thin films and their interfaces for new generation of oxide-based microelectronic devices.
Notice of Issuance of an amended Export Trade Certificate of Review to Northwest Fruit Exporters (“NFE”), Application No. 84-29A12.
The Secretary of Commerce, through the Office of Trade and Economic Analysis (“OTEA”), issued an amended Export Trade Certificate of Review to NFE on October 9, 2018. A previous amended Export Trade Certificate of Review was issued to NFE on October 24, 2016, and a notice of its issuance was published in the
Joseph Flynn, Director, OTEA, International Trade Administration, by telephone at (202) 482-5131 (this is not a toll-free number) or email at
Title III of the Export Trading Company Act of 1982 (15 U.S.C. Sections 4001-21) (“the Act”) authorizes the Secretary of Commerce to issue Export Trade Certificates of Review. An Export Trade Certificate of Review protects the holder and the members identified in the Certificate from State and Federal government antitrust actions and from private treble damage antitrust actions for the export conduct specified in the Certificate and carried out in compliance with its terms and conditions. The regulations implementing Title III are found at 15 CFR part 325 (2018). OTEA is issuing this notice pursuant to 15 CFR 325.6(b),
NFE's Export Trade Certificate of Review has been amended as follows:
(a) Added the following companies as new Members of the Certificate within the meaning of section 325.2(l) of the Regulations (15 CFR 325.2(l)):
(b) Deleted the following companies as Members of the Certificate:
(c) Changed the name of the following Members of the Certificate:
(d) Corrected the name of the following Members of the Certificate:
NFE's Export Trade Certificate of Review Membership, as amended, is below:
The effective date of the amendment is July 10, 2018, the date on which NFE's application to amend was deemed submitted.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (Commerce) determines that Datong Juqiang Activated Carbon Co. Ltd. (Datong Juqiang) and Carbon Activated Tianjin Co., Ltd. (Carbon Activated) sold activated carbon from the People's Republic of China at less than normal value (NV) during the period of review (POR) April 1, 2016, through March 31, 2017.
Applicable October 22, 2018.
John Anwesen or Jinny Ahn, AD/CVD Operations, Office VIII, Enforcement and Compliance, International Trade Administration, Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-0131, or (202) 482-0339, respectively.
Commerce published the
The merchandise subject to the
In the Issues and Decision Memorandum, we addressed all issues raised in parties' case and rebuttal briefs. In Appendix I to this notice, we provided a list of the issues raised by parties. The Issues and Decision Memorandum is a public document and is on file in the Central Records Unit (CRU), Room B8024 of the main Department of Commerce building, as well as electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at
Based on our review of the record and comments received from interested parties regarding our
In the
In our
The statute and our regulations do not address the establishment of a rate to be assigned to respondents not selected for individual examination when we limit our examination of companies subject to the administrative review pursuant to section 777A(c)(2)(B) of the Act. Generally, we look to section 735(c)(5) of the Act, which provides instructions
For the final results, we calculated a rate only for Carbon Activated that was not zero,
For companies subject to this review, which established their eligibility for a separate rate, Commerce determines that the following weighted-average dumping margins exist for the POR from April 1, 2016, through March 31, 2017:
In the
Pursuant to section 751(a)(2)(C) of the Act and 19 CFR 351.212(b), Commerce has determined, and U.S Customs and Border Protection (CBP) shall assess, antidumping duties on all appropriate entries covered by this review. We intend to issue assessment instructions to CBP 15 days after the publication date of these final results of review.
For each individually-examined respondent in this review which has a final weighted-average dumping margin that is not zero or
For the respondents which were not selected for individual examination in this administrative review and which qualified for a separate rate, the assessment rate will be equal to the rate assigned to them for the final results (
For the companies identified in Appendix II as part of the China-wide entity, we will instruct CBP to apply a per-unit assessment rate of 2.42 USD/kg to all entries of subject merchandise during the POR which were produced or exported by those companies.
Pursuant to a refinement in our non-market economy practice, for sales that were not reported in the U.S. sales data submitted by companies individually examined during this review, we will instruct CBP to liquidate entries associated with those sales at the rate for the China-wide entity. Furthermore, where we found that an exporter under review had no shipments of the subject merchandise, any suspended entries that entered under that exporter's case number (
The following per-unit cash deposit requirements will be effective upon publication of the final results of this administrative review for all shipments of the subject merchandise from China entered, or withdrawn from warehouse, for consumption on or after the
We intend to disclose the calculations performed to parties in this proceeding within five days of the date of publication of this notice in accordance with 19 CFR 351.224(b).
This notice also serves as a final reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this POR. Failure to comply with this requirement could result in Commerce's presumption that reimbursement of antidumping duties has occurred and the subsequent assessment of double antidumping duties.
This notice also serves as a reminder to parties subject to 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(a)(3), which continues to govern business proprietary information in this segment of the proceeding. Timely written 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 final results of administrative review and notice in accordance with sections 751(a)(1) and 777(i) of the Act.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of a public meeting.
The Gulf of Mexico Fishery Management Council (Council) will hold a meeting of its Ad Hoc Red Snapper and Grouper-Tilefish Individual Fishing Quota (IFQ) Advisory Panel.
The meeting will convene on Wednesday, November 7, 2018; starting 8:30 a.m. and will adjourn at 5 p.m.
The meeting will be held at the Gulf Council's office, 4107 W Spruce Street, Suite 200, Tampa, FL 33607; telephone: (813) 348-1630.
Dr. Ava Lasseter, Anthropologist, Gulf of Mexico Fishery Management Council;
The items of discussion on the agenda are as follows:
The Agenda is subject to change, and the latest version along with other meeting materials will be posted on
Although other non-emergency issues not on the agenda may come before the Advisory Panel for discussion, in accordance with the Magnuson-Stevens Fishery Conservation and Management Act, those issues may not be the subject of formal action during this meeting. Actions of the Advisory Panel will be restricted to those issues specifically identified in the agenda and any issues
This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Kathy Pereira at the Gulf Council Office (see
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; issuance of 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 the Port of San Francisco to incidentally harass, by Level B harassment only, marine mammals during construction activities associated with the pile driving, pile removal, and drilling on the Mission Bay Ferry Landing (MBFL) and Water Taxi Landing (WTL) Project in San Francisco Bay, California.
This Authorization is effective from June 1, 2019, to May 31, 2020.
Gray Redding, Office of Protected Resources, NMFS, (301) 427-8401. Electronic copies of the application and supporting documents, as well as a list of the references cited in this document, may be obtained online at:
The MMPA prohibits the “take” of marine mammals, with certain exceptions. Sections 101(a)(5)(A) and (D) of the MMPA (16 U.S.C. 1361
Authorization for incidental takings shall be granted if NMFS finds that the taking will have a negligible impact on the species or stock(s) and will not have an unmitigable adverse impact on the availability of the species or stock(s) for taking for subsistence uses (where relevant). Further, NMFS must prescribe the permissible methods of taking and other means of effecting the least practicable adverse impact on the affected species or stocks and their habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance, and on the availability of such species or stocks for taking for certain subsistence uses (referred to in shorthand as “mitigation”); and requirements pertaining to the mitigation, monitoring and reporting of such takings are set forth. The definitions of all applicable MMPA statutory terms cited above are included in the relevant sections below.
On November 2, 2017, NMFS received a request from the Port of San Francisco for an IHA to take marine mammals incidental to pile driving and drilling in San Francisco Bay. NMFS determined that a revised version of the Port's application was adequate and complete on June 22, 2018. The Port of San Francisco's request was for take of seven species of marine mammals by Level B harassment only. This authorization is valid from June 1, 2019, to May 31, 2020. Neither the Port of San Francisco nor NMFS expects serious injury or mortality to result from this activity and, therefore, an IHA is appropriate.
The Port of San Francisco plans to construct the MBFL and WTL on San Francisco Bay, within the Port of San Francisco's Southern Waterfront in the Mission Bay/Central Waterfront area. The project will create two, two-berth, floating landings to add ferry and water taxi access to the area. The project's activities that have the potential to take marine mammals include vibratory and impact pile driving, vibratory pile removal, and down the hole drilling. In total, 28 permanent piles ranging from 16-inch to 36-inch in diameter will be installed, but only 24 will require in water installation. Twelve older piles will be removed, and four 14-inch H-piles and one 30-inch steel pile will be driven temporally to act as the caisson and supports during down the hole drilling at 10 locations. In addition, the project will include dredging, however authorization of take from this activity is neither requested nor proposed for authorization. All piles will be driven between June 1, 2019 and November 20, 2019.
A detailed description of the planned Port of San Francisco MBFL and WTL project is provided in the
While there were not changes to the planned activity, some errors were corrected and other minor changes occurred following publication of the proposed IHA. These changes are outlined in each section of this notice In this section, the rate of pile installation for 36-inch steel piles was corrected from 5 piles per day to 4, to address an inconsistency in the application and more accurately reflect the applicant's expected schedule.
A notice of NMFS's proposal to issue an IHA to the Port of San Francisco was published in the
Bubble curtains are effective at attenuating sound originating within the water column. Pile driving does generate sound within the seafloor as well. This sound travels within the seafloor and emerges back to the water column, but its intensity is reduced within the sediment due to absorption by the sediment and reflection at the sediment/water interface.
NMFS will evaluate the appropriateness of using a certain source level reduction factor for sound attenuation device implementation during impact pile driving for all relevant incidental take authorizations when more data become available.
A detailed description of the species likely to be affected by the Port of San Francisco's MBFL and WTL project, 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
Table 2 lists all species with expected potential for occurrence in the Mission Bay/Central Waterfront area of San Francisco Bay 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 the 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's Stock Assessment Report (SAR)). While NMFS neither anticipates nor proposes to authorize mortality here, PBR and annual serious injury and mortality from anthropogenic sources are included here as gross indicators 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's 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's U.S. 2017 SAR (Carretta
All species that could potentially occur in the Port's proposed project area in San Francisco Bay are included in Table 2. However, the temporal and/or spatial occurrence of humpback whale and Guadalupe fur seal is such that take is not expected to occur, and they are not discussed further beyond the explanation provided here. Humpback whales are rare visitors to the interior of San Francisco Bay. A recent, seasonal influx of humpback whales inside San Francisco Bay near the Golden Gate was recorded from April to November in 2016 and 2017 (Keener 2017). The Golden Gate is outside of this project's action area and humpback whales are not expected to be present during the project. Guadalupe fur seals occasionally range into the waters of northern California and the Pacific Northwest. The Farallon Islands (off central California) and Channel Islands (off southern California) are used as haulouts during these movements (Simon 2016). Juvenile Guadalupe fur seals occasionally strand in the vicinity of San Francisco, especially during El Niño events. Most strandings along the California coast are animals younger than two years old, with evidence of malnutrition (NMFS 2017a). Because Guadalupe fur seals are rare in the area, and sightings are associated with abnormal weather conditions, such as El Niño events, NMFS has determined that no Guadalupe fur seals are likely to occur in the project vicinity and, therefore, no take is expected to occur.
The effects of underwater noise from pile driving, pile removal, and drilling activities for the MBFL and WTL Project in San Francisco Bay, California have the potential to result in behavioral harassment of marine mammals in the vicinity of the action area. The
The main impact associated with the Port of San Francisco's MBFL and WTL project would be temporarily elevated sound levels and the associated direct effects on marine mammals. The project would not result in permanent impacts to habitats used directly by marine mammals, such as haulout sites, but may have potential short-term impacts to food sources such as forage fish, and minor impacts to the immediate substrate during installation/removal of piles and drilling during the MBFL and WTL project. These potential effects are discussed in detail in the
This section provides an estimate of the number of incidental takes for authorization through this IHA, which will inform both NMFS' consideration of “small numbers” and the negligible impact determination.
After public comment and review of the proposed authorization, the following items have changed in the final authorization.
(1) The Level B harassment zone for drilling activities has decreased from 21,544 m to 15,849 m to account for an error that was present in the proposed IHA. During the drafting of the proposed IHA, the source level for drilling activities was reduced from 170 dB to 168 dB based on proxy data from the Alaska Department of Transportation (2016). The resulting Level B harassment zone was not updated from 21,544 m to 15,849 m until this error was noticed during public comment (Table 5).
(2) The Level B harassment zone for impact driving of 16-inch steel piles changed from 215 m to 136 m to account for an error that was present in the proposed IHA. This change resulted in a corresponding correction the ensonified area (Table 5).
(3) The Level B harassment zone for vibratory installation of 16-inch steel pipe piles was reduced from 21,544 m to 3,415 m. This change was to correct a misstatement in the proposed IHA. The original Level B harassment zone was stated as 21,544 m, when 3,415 m was the correct value for the given source level (158 dB SPL). This source level remains at 158 dB as presented in the proposed IHA, and the Level B harassment zone has been updated to match this source level with a corresponding correction to the ensonified area (Table 5).
(4) To correct errors present in the proposed IHA, duration estimates for some activities were updated. Updated activity durations included vibratory pile removal, vibratory pile installation of 36-inch steel piles, vibratory pile installation of 14-inch steel H piles, and down the hole drilling (Table 6). These changes were accompanied by corresponding but minor changes in Level A harassment zones (Table 7).
(5) Errors in calculation of takes by Level B harassment for harbor seal, California sea lion, and harbor porpoise were corrected, resulting in decreased take estimates. Take estimates for northern elephant seal and northern fur seal were increased from 1 to 3 individuals to account for the large Level B harassment zones for certain activities (Table 9).
Harassment is the only type of take expected to result from these activities. Except with respect to certain activities not pertinent here, section 3(18) of 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 would be by Level B harassment only, in the form of disruption of behavioral patterns for individual marine mammals resulting from exposure to acoustic sources. Based on the nature of the activity and the anticipated effectiveness of the mitigation measures (
As described previously, no mortality is anticipated or authorized for this activity. Below we describe how the take is estimated.
Generally speaking, 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. We note that while these basic factors can contribute to a basic calculation to provide an initial prediction of takes, additional information that can qualitatively inform take estimates is also sometimes available (
Using the best available science, NMFS has developed 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).
Level B Harassment for non-explosive sources—Though significantly driven by received level, the onset of behavioral disturbance from anthropogenic noise exposure is also informed to varying degrees by other factors related to the source (
The Port of San Francisco's activity includes the use of continuous (vibratory pile driving, down the hole drilling) and impulsive (impact pile driving) sources, and therefore the 120 and 160 dB re 1 μPa (rms) thresholds are applicable.
Level A harassment for non-explosive sources—NMFS' Technical Guidance for Assessing the Effects of Anthropogenic Sound on Marine Mammal Hearing (Version 2.0) (NMFS, 2018) identifies dual criteria to assess auditory injury (Level A harassment) to five different marine mammal groups (based on hearing sensitivity) as a result of exposure to noise from two different types of sources (impulsive or non-impulsive). The Port of San Francisco's activity includes the use of impulsive (impact pile driving) and non-impulsive (vibratory pile driving) sources.
These thresholds are provided in Table 3 below. The references, analysis, and methodology used in the development of the thresholds are described in NMFS's 2018 Technical Guidance, which may be accessed at:
Here, we describe operational and environmental parameters of the activity that will feed into identifying the area ensonified above the acoustic thresholds, which include source levels and transmission loss coefficients.
Reference sound source levels used by the Port of San Francisco for all vibratory and impact piling/removal and drilling activities were derived from source level data from construction projects within Caltrans (2015) except for two cases noted below where Navy and Alaska Department of Transportation sources were used. To determine the ensonified areas for both the Level A and Level B harassment zones for vibratory piling of the 36-inch, 30-inch, and 16-inch steel piles and 14-inch steel H piles, the Port of San Francisco used sound pressure levels (SPL) of 170 dB re 1 μPa rms, 170 dB re 1 μPa rms, 158 dB re 1 μPa rms, and 158 dB re 1 μPa rms, respectively. These were derived from vibratory pile driving data of 36-inch (for 36-inch and 30-inch steel piles), 18-inch (for 16-inch steel piles) and 14-inch (for 14-inch steel H-pile) steel piles reported in the values listed in Table 1.2-2 and Table 1.2.3 of Caltrans (2015), and Table 6-1 of Navy (2017). For vibratory pile removal, the Port of San Francisco used an SPL of 155 dB re 1 μPa rms. This proxy source level was derived from vibratory pile driving data of 12-inch steel pipe piles in Caltrans (2015; Table 1.2-2). In addition, for down the hole drilling activities used to place 24-inch octagonal concrete piles, an SPL of 168 dB was used, corresponding to the mean SPL reported in Table 72 of the Alaska Department of Transportation (2016) hydroacoustic report.
For impact pile driving, the Port of San Francisco used both SPLs and sound exposure levels (SEL) derived from summary source level values reported in Caltrans (2015). These source levels were then reduced by 7 dB due to the Port of San Francisco's use of a bubble curtain. NMFS used a reduction value of 7 dB as it was roughly the average sound reduction value derived from sound measurements of piles that used bubble curtains within Caltrans (2015). For piling of 36-inch steel piles, a source level of 183 dB SEL was chosen as a proxy value for modeling Level A harassment zones (Caltrans 2015, Table 1.2-1). This source level was reduced to 176 dB SEL with the 7 dB reduction. For piling of 20-inch concrete piles, a source level of 167 dB SEL was chosen as a proxy value for modeling Level A harassment zones (Caltrans 2015, Table 1.5-4, reported from 24-inch concrete pile measurements at a project in the Port of Oakland). This source level was selected as a proxy because of the proximity of the Port of Oakland project to the proposed work and it is more conservative than Caltrans (2015) summary value reported in Table 1.2-1. This source level was reduced to 160 dB SEL with the 7 dB reduction. In addition, for impact piling of 16-inch steel piles, a source level of 158 dB SEL was chosen as a proxy value for modeling Level A harassment zones (Caltrans 2015, Table I.2-1). This source level was reduced to 151 dB SEL with the 7 dB reduction. The stated source levels and their corresponding activity are presented in Table 4 below.
The practical spreading model was used by the Port of San Francisco to generate the Level B harassment zones for all piling/removal activities. Practical spreading is described in full detail below.
Pile driving and drilling generates underwater noise that can potentially result in disturbance to marine mammals in the project area. Transmission loss (TL) is the decrease in acoustic intensity as an acoustic pressure wave propagates out from a source. TL parameters vary with frequency, temperature, sea conditions, current, source and receiver depth, water depth, water chemistry, and bottom composition and topography. The general formula for underwater TL is:
Utilizing the practical spreading loss model, the Port of San Francisco determined underwater noise will fall below the behavioral effects threshold of 120 dB rms for marine mammals at a maximum radial distance of 21,544 m for vibratory piling (36 and 30-inch steel piles) and 15,849 m for drilling ((24-inch octagonal concrete pile). The maximum Level B harassment zone for this activity will therefore be set at 21,544 m. However, previous sound monitoring for other projects in San Francisco Bay (
When the NMFS Technical Guidance (2016) was published, in recognition of the fact that the ensonified area could be more technically challenging to predict because of the duration component in the new thresholds, we developed a User Spreadsheet that includes tools to help predict a simple isopleth that can be used in conjunction with marine mammal density or occurrence to help predict takes. We note that because of some of the assumptions included in the methods used for these tools, we anticipate that isopleths produced are typically going to be overestimates of some degree, which will result in some overestimate of Level A harassment. However, these tools offer the best way to predict appropriate isopleths when more sophisticated 3D modeling methods are not available, and NMFS continues to develop ways to quantitatively refine these tools, and will qualitatively address the output where appropriate. For stationary sources (
In this section we provide the information about the presence, density, or group dynamics of marine mammals that will inform the take calculations.
No systematic line transect surveys of marine mammals have been performed in San Francisco Bay. Therefore, the in-water densities of harbor seals, California sea lions, and harbor porpoises were calculated based on 17 years of observations during monitoring for the San Francisco Bay-Oakland Bay Bridge (SFOBB) construction and demolition project (Caltrans 2018). Care was taken to eliminate multiple observations of the same animal, although this can be difficult and is likely that the same individual may have been counted multiple times on the same day. The amount of monitoring
Insufficient sighting data exist to estimate the density of bottlenose dolphins. However, a single bottlenose dolphin has been observed regularly near the project site. One individual was documented regularly, through photo ID, over several months off the coast of the former Alameda Air Station (Perlman 2017).
Insufficient sighting data exist to estimate elephant seal densities in the Bay. Generally, only juvenile elephant seals enter the Bay and do not remain long. The most recent sighting near the project area was in 2012, on the beach at Clipper Cove on Treasure Island, when a healthy yearling elephant seal hauled out for approximately 1 day. Approximately 100 juvenile northern elephant seals strand in or near the Bay each year, including individual strandings at Yerba Buena Island and Treasure Island (less than 10 strandings per year).
In addition, insufficient sighting data exist to estimate northern fur seal and gray whale densities in the Bay. Only two to four northern fur seals strand in the Bay each year, and they are unlikely to occur in the project area. Also, during the Caltrans Richmond-San Rafael Bridge project, monitors recorded 12 living and two dead gray whales in the surveys performed in 2012. All sightings were in either the Central or North Bay, and all but two sightings occurred during the months of April and May. One gray whale was sighted in June and one in October. The Oceanic Society has tracked gray whale sightings since they began returning to San Francisco Bay regularly in the late 1990s. Most sightings occurred just a mile or two inside of the Golden Gate, with some traveling into San Pablo Bay in the northern part of the San Francisco Bay (Self 2012). The Oceanic Society data show that all age classes of gray whales enter San Francisco Bay and they enter as singles or in groups of up to five individuals (Winning 2008). It is estimated that two to six gray whales enter San Francisco Bay in any given year.
Numbers used for density calculations are shown in Table 8. These numbers were calculated from observations in nearby waters of the San Francisco Bay during San Francisco-Oakland Bay Bridge construction conducted by Caltrans (Caltrans 2018). These observations occurred from 2000 to 2017 in a 2 km
For species without enough sightings to construct a density estimate, we used information based on group size and frequency of sightings from previous years of work to inform the number of animals estimated to be taken, which is detailed in the Take Estimation section below.
Here we describe how the information provided above is brought together to produce a quantitative take estimate.
When density data was available, Level B take for the project was calculated by multiplying the density times the largest Level B harassment zone (km
Gray whales occasionally enter San Francisco Bay during their northward migration period of February and March. Pile driving and drilling are not proposed to occur during this time and gray whales are not likely to be present at other times of the year. It is estimated that two to six gray whales enter the Bay in any given year, but they are unlikely to be present during the work period (June 1 through November 30). However, individual gray whales have occasionally been observed in San Francisco Bay during the work period, and therefore it is conservatively estimated that, at most, 3 gray whales, or one average sized group, may be exposed to Level B harassment during the 15 days of pile driving/drilling.
When bottlenose dolphins are present in San Francisco Bay, they are more typically found close to the Golden Gate. Recently, beginning in 2015, two individuals have been observed frequently in the vicinity of Oyster Point (GGCR 2016, 2017; Perlman 2017) and one individual has been observed near Alameda (GGCR 2016). Observations of bottlenose dolphins are primarily west of Treasure Island and concentrated along the nearshore areas of San Francisco south to Redwood City (Caltrans 2018). Bottlenose dolphins rarely occur in San Francisco Bay, but given the size of the Level B harassment zone NMFS authorizes take of 15 bottlenose dolphins by level B harassment.
Observations of northern fur seals are too few to establish a density for this species in San Francisco Bay. The Marine Mammal Center (TMMC) reported only two to four northern fur seal strandings in the Bay in 2015 and 2016 (in Marin, San Francisco, and Santa Clara counties) (TMMC 2017). To account for the possible rare presence of the species in the action area, NMFS authorizes three takes by Level B harassment of northern fur seal.
Elephant seals breed between December and March and have been rarely cited in San Francisco Bay. It is anticipated that if an elephant seal is encountered at all during pile driving or drilling it would be a juvenile. To account for the possible rare presence of the species in the action area, NMFS authorizes three takes by Level B harassment of elephant seal.
High frequency cetaceans (including harbor porpoise) have the largest Level A harassment zone resulting from this project as shown in Table 7. Estimated take by Level A harassment for harbor porpoise, based on density reported in Table 8 and the Level A harassment zone, is less than one individual (Density * Days * Ensonified Area). Given the required mitigation measures, including shutdown zones which exceed the Level A harassment zone, NMFS authorizes no Level A harassment for harbor porpoise or any marine mammal.
The only change to mitigation measures were updates to the minimum shutdown zones to reflect the changes in Level A harassment zones discussed in the previous section.
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
(2) The practicability of the measures for applicant implementation, which may consider such things as cost, impact on operations.
In addition to the specific measures described later in this section, the Port must conduct briefings for construction supervisors and crews, the monitoring team, and Port staff prior to the start of all pile driving activity, and when new personnel join the work, in order to explain responsibilities, communication procedures, the marine mammal monitoring protocol, and operational procedures.
All work will be conducted during daylight hours. If poor environmental conditions restrict full visibility of the shutdown zone, pile installation would be delayed.
Sound attenuation methods, including a bubble curtain, will be implemented for the duration of impact pile driving to install 36-inch and 16-inch steel and 20-inch concrete piles. Additionally, a caisson sleeve will be used during down the whole drilling. The Port shall implement the following bubble curtain performance standards:
• The bubble curtain must distribute air bubbles around 100 percent of the piling perimeter for the full depth of the water column;
• The lowest bubble ring shall be in contact with the mudline for the full circumference of the ring, and the weights attached to the bottom ring shall ensure 100 percent mudline contact. No parts of the ring or other objects shall prevent full mudline contact;
• The selected contractor will ensure that personnel are trained in the proper balancing of air flow to the bubblers and shall require that construction contractors submit an inspection/performance report for approval by the Port of San Francisco within 72 hours following the performance test. Corrections to the attenuation device to meet the performance standards shall occur prior to impact driving.
For in-water heavy machinery work (using,
For all pile driving/removal and drilling activities, The Port of San Francisco will establish a shutdown zone for a marine mammal species that is greater than its corresponding Level A harassment zone. The purpose of a shutdown zone is generally to define an area within which shutdown of the activity would occur upon sighting of a marine mammal (or in anticipation of an animal entering the defined area). The shutdown zones for each of the pile driving and drilling activities are listed below in Table 10.
The Port of San Francisco will establish and observe a monitoring zone. The monitoring zones for this project will differ based on activity. For vibratory pile driving and down the hole drilling, it may not be possible to observe the entire Level B harassment zones (areas where SPLs are equal to or exceed 120 dB rms) due to their size. The Port is expected to monitor and record observations in the largest reasonable portion of this Level B harassment zone based on the number of observers and visibility, but conditions may require efforts to be focused in a smaller monitoring zone. For impact pile driving, the monitoring zones are areas where SPLs are equal to or exceed 160 dB rms. For vibratory pile driving/drilling and impact pile driving the Level B Harassment zones are presented in Table 11 below. For the vibratory pile driving and drilling activities, it is noted that Level B harassment zone radius and area will not necessarily equal the monitoring zone. These zones provide utility for monitoring conducted for mitigation purposes (
If a species enters or approaches the Level B harassment zone and that species is either not authorized for take or its authorized takes are met, pile driving, pile removal, and drilling activities must shut down immediately using delay and shut-down procedures. Activities must not resume until the animal has been confirmed to have left the area or an observation time period of 15 minutes has elapsed.
The use of a soft-start procedure is believed to provide additional protection to marine mammals by providing warning and/or giving marine mammals a chance to leave the area prior to the impact hammer operating at full capacity. For impact pile driving, contractors will be required to provide an initial set of strikes from the hammer at 40 percent energy, each strike followed by no less than a 30-second waiting period. This procedure will be conducted a total of three times before impact pile driving begins. This soft start procedure must be implemented at the start of a day's impact pile driving and at any time following cessation of impact driving of 30 minutes or greater. Soft start is not required during vibratory pile driving/removal or drilling activities.
Prior to the start of daily in-water construction activity, or whenever a break in pile driving or drilling of 30 minutes or longer occurs, the observer will observe the shutdown and monitoring zones for a period of 30 minutes. The shutdown zone will be cleared when a marine mammal has not been observed within the zone for that 30-minute period. A determination that the shutdown zone is clear must be made during a period of good visibility (
Based on our evaluation of the applicant's mitigation measures, as well as other measures considered by NMFS, NMFS has determined that the mitigation measures provide the means effecting the least practicable impact on
Between the proposed IHA and final IHA, the only change to monitoring and reporting protocols were a decrease in the required minimum number of protected species observers (PSOs) from two to one. To minimize the burden of monitoring on the applicant, two PSOs will be used for the first week of the project. Later portions of the project will utilize one PSO if monitoring results up to that point have not shown unexpectedly high numbers of marine mammals. NMFS determined that one PSO is sufficient to effectively observe the shutdown zones and a portion of the monitoring zone. This level of observation minimized burden on the applicant while still ensuring effective monitoring. Additionally, the use of two PSOs for a portion of the project will increase understanding of the impacts of this and similar projects on marine mammals in San Francisco Bay, while not placing an excessive burden on the Port of San Francisco.
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.
The Port recognizes in their application the need to implement a sound monitoring plan (SMP) as required by the Regional NMFS and U.S. Army Corps of Engineers programmatic review for pile driving activities in San Francisco Bay. The Port indicates that this SMP will recommend sound monitoring stations at 10 m, 100 m, and 300 m to monitor ambient noise conditions in the area. NMFS feels that ambient noise measurements are highly specific to the time and place they were taken, and therefore might have limited use to future projects. However, there are few source level measurements for down the hole drilling activities, as shown by the use of Alaska DOT proxy data in this IHA. NMFS feels that rigorous hydroacoustic monitoring of source level for the down the hole drilling activity will be more beneficial for future projects in this region and others. While NMFS is not requiring these source level measurements, if the Port were already planning to conduct measurements, we recommend focusing on source level verification and could offer guidance on its implementation.
Monitoring would be conducted 30 minutes before, during, and 30 minutes after all pile driving/removal and drilling activities. In addition, observers shall record all incidents of marine mammal occurrence, regardless of distance from activity, and shall document any behavioral reactions in concert with distance from piles being driven, removed, or pile holes being drilled. Pile driving and drilling activities include the time to install, remove, or drill a hole for a single pile or series of piles, as long as the time elapsed between uses of the pile driving equipment is no more than thirty minutes.
Monitoring will be conducted by NMFS approved PSOs. There will be a minimum of one PSO during all pile driving/removal and drilling activities. Two PSOs will be required to observe the shutdown and disturbance zones for the first five (5) days of combined pile driving, pile removal, and drilling.
PSOs shall scan the waters using binoculars, and/or spotting scopes, and shall use a handheld GPS or range-finder device to verify the distance to each sighting from the project site. All PSOs shall be trained in marine mammal identification and behaviors and are required to have no other project-related tasks while conducting monitoring. In addition, monitoring shall be conducted by qualified observers, who shall be placed at the best vantage point(s) practicable to monitor for marine mammals and implement shutdown/delay procedures when applicable by calling for the shutdown to the hammer operator. Qualified observers are trained and/or experienced professionals, with the following minimum qualifications:
i. At least one PSO must have prior experience working as a marine mammal observer during construction activities;
• Independent observers (
ii. Other PSOs may substitute education (degree in biological science or related field) or training for experience;
iii. Where a team of three or more PSOs are required, a lead observer or monitoring coordinator shall be designated. The lead observer must have prior experience working as a marine mammal observer during construction;
iv. The Port of San Francisco shall submit PSO CVs for approval by NMFS;
• Visual acuity in both eyes (correction is permissible) sufficient for discernment of moving targets at the water's surface with ability to estimate target size and distance; use of binoculars may be necessary to correctly identify the target;
• Ability to conduct field observations and collect data according to assigned protocols;
• Experience or training in the field identification of marine mammals, including the identification of behaviors;
• Writing skills sufficient to prepare a report of observations including but not limited to the number and species of
• Ability to communicate orally, by radio or in person, with project personnel to provide real-time information on marine mammals observed in the area as necessary; and
• Sufficient training, orientation, or experience with the construction operations to provide for personal safety during observations.
The Port of San Francisco shall submit a draft report to NMFS not later than 90 days following the end of construction activities. The Port of San Francisco shall provide a final report within 30 days following resolution of NMFS' comments on the draft report. Reports shall contain, at minimum, the following:
• Date and time that monitored activity begins and ends for each day conducted (monitoring period);
• Construction activities occurring during each daily observation period, including how many and what type of piles driven;
• Deviation from initial proposal in pile numbers, pile types, average driving times, etc.;
• Weather parameters in each monitoring period (
• Water conditions in each monitoring period (
• Extrapolated estimates of the total observed Level B harassment takes based on the percentage of the Level B harassment zone that was not visible or was not monitored.
• For each marine mammal sighting:
○ Species, numbers, and, if possible, sex and age class of marine mammals;
○ Description of any observable marine mammal behavior patterns, including bearing and direction of travel and distance from pile driving activity;
○ Location and distance from pile driving activities to marine mammals and distance from the marine mammals to the observation point;
○ Estimated amount of time that the animals remained in the Level B harassment zone;
○ Description of implementation of mitigation measures within each monitoring period (
○ Other human activity in the area within each monitoring period; and
○ A summary of the following:
Total number of individuals of each species detected within the monitoring zone, and estimated as taken if correction factor appropriate;
Total number of individuals of each species detected within the Level A harassment zone and the average amount of time that they remained in that zone; and
Daily average number of individuals of each species (differentiated by month as appropriate) detected within the monitoring zone, and estimated as taken, if appropriate.
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 (50 CFR 216.103). A negligible impact finding is based on the lack of likely adverse effects on annual rates of recruitment or survival (
As stated in the mitigation section, bubble curtains will be used and shutdown zones that encompass the area in which Level A harassment might be expected to occur will be implemented. As a result, no take by Level A harassment is expected nor authorized for this activity. Exposures to elevated sound levels produced during pile driving activities may cause behavioral responses by an animal, but they are expected to be mild and temporary. Effects on individuals that are taken by Level B harassment, on the basis of reports in the literature as well as monitoring from other similar activities, will likely be limited to reactions such as increased swimming speeds, increased surfacing time, or decreased foraging (if such activity were occurring) (
During all impact driving, implementation of soft start procedures, the use of a bubble curtain, and monitoring of established shutdown zones will be required. Given sufficient notice through use of soft start (for impact driving), marine mammals are expected to move away from an irritating sound source prior to it becoming potentially injurious. In addition, PSOs will be stationed within the action area whenever pile driving/removal and drilling operations are underway. Depending on the activity, The Port of San Francisco will employ the use of at least one PSO to monitor shutdown and monitoring zones.
Although the MBFL and WTL Project would have some permanent removal of habitat available to marine mammals, the area lost would be negligible. Construction of the MBFL and WTL structures and dredging for the project will result in the disturbance of up to approximately 8.4 acres of predominantly fine‐grained sediment and the associated benthic infaunal community. Total habitat disturbed from the project activities is estimated at 0.000071 percent of the total South San Francisco Bay subtidal habitat available (NOAA 2007). This is a relatively small fraction of area relative to the total available habitat for foraging and transit for marine mammals. In addition, to minimize impacts, in‐water construction will be limited to locally established environmental work windows between June and November.
Overall, impacts to marine mammals and prey species due to the Mission Bay Ferry and Water Taxi Landing Project are expected to be minor and temporary. The area impacted by the project is very
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:
• Mortality is not anticipated or authorized;
• Minimal impacts to marine mammal habitat are expected;
• Bubble curtain and other sound attenuating devices are used during impact pile driving will lessen the amount of behavioral disturbance and contribute to the alleviation of the likelihood of injury;
• Impacts are not occurring in rookeries, or known areas or features of special significance for foraging or reproduction in the project area;
• Anticipated incidents of Level B harassment consist of, at worst, temporary modifications in behavior; and
• Required mitigation measures (
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.
Take for all species authorized except harbor seal is less than five percent of their respective stock abundance. For harbor seal, the authorized take is less than 10 percent of the stock abundance. Based on this and the analysis contained herein of the proposed activity (including the proposed 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.
To comply with the National Environmental Policy Act of 1969 (NEPA; 42 U.S.C. 4321
This action is consistent with categories of activities identified in Categorical Exclusion B4 (incidental harassment authorizations with no anticipated serious injury or mortality) of the Companion Manual for NOAA Administrative Order 216-6A, which do not individually or cumulatively have the potential for significant impacts on the quality of the human environment and for which we have not identified any extraordinary circumstances that would preclude this categorical exclusion. Accordingly, NMFS has determined that the issuance of the IHA qualifies to be categorically excluded from further NEPA review.
No incidental take of ESA-listed species is proposed for authorization or expected to result from this activity. Therefore, NMFS has determined that formal consultation under section 7 of the ESA is not required for this action.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of public meetings.
The South Atlantic Fishery Management Council (Council) will hold a meeting of its Habitat Protection and Ecosystem-Based Management Advisory Panel (AP).
The Habitat Protection and Ecosystem-Based Management AP meeting will take place November 6, 2018, from 9 a.m. to 4:30 p.m., November 7, 2018, from 9 a.m. until 4:30 p.m., and November 8, 2018, from 9 a.m. until 12 p.m.
Kim Iverson, Public Information Officer, SAFMC; phone: (843) 571-4366 or toll free (866) SAFMC-10; fax: (843) 769-4520; email:
The Habitat Protection and Ecosystem-Based Management AP meeting is open to the public and will be available via webinar as it occurs. Registration is required. Webinar registration information and other meeting materials will be posted to the Council's website at:
The Habitat Protection and Ecosystem-Based Management AP meeting agenda will include the following: An update on the Final Environmental Impact Statement for the Navy Fleet Training and Testing Area cooperatively developed by the Navy
These meetings are physically accessible to people with disabilities. Requests for auxiliary aids should be directed to the Council office (see
The times and sequence specified in this agenda are subject to change.
16 U.S.C. 1801
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of SEDAR 63 Review Workshop for Gulf of Mexico Menhaden.
The SEDAR 63 assessment of the Gulf of Mexico stock of Menhaden will be reviewed by an independent Panel at the Review Workshop. See
The SEDAR 63 Review Workshop will be held on November 6, 2018, from 8:30 a.m. until 6 p.m.; and November 7, 2018, from 8:30 a.m. until 3:30 p.m. The established times may be adjusted as necessary to accommodate the timely completion of discussion relevant to the assessment process. Such adjustments may result in the meeting being extended from, or completed prior to the time established by this notice.
Julia Byrd, SEDAR Coordinator, 4055 Faber Place Drive, Suite 201, North Charleston, SC 29405; phone: (843) 571-4366; email:
The Gulf of Mexico, South Atlantic, and Caribbean Fishery Management Councils, in conjunction with NOAA Fisheries and the Atlantic and Gulf States Marine Fisheries Commissions, have implemented the Southeast Data, Assessment and Review (SEDAR) process, a multi-step method for determining the status of fish stocks in the Southeast Region. SEDAR is a three-step process including: (1) Data Workshop; (2) Assessment Process utilizing a workshop and webinars; and (3) Review Workshop. The product of the Data Workshop is a data report, which compiles and evaluates potential datasets and recommends which datasets are appropriate for assessment analyses. The product of the Assessment Process is a stock assessment report, which describes the fisheries, evaluates the status of the stock, estimates biological benchmarks, projects future population conditions, and recommends research and monitoring needs. The assessment is independently peer reviewed at the Review Workshop. The product of the Review Workshop is a Summary documenting panel opinions regarding the strengths and weaknesses of the stock assessment and input data. Participants for SEDAR Workshops are appointed by the Gulf of Mexico, South Atlantic, and Caribbean Fishery Management Councils and NOAA Fisheries Southeast Regional Office, Highly Migratory Species Management Division, and Southeast Fisheries Science Center. Participants include: Data collectors and database managers; stock assessment scientists, biologists, and researchers; constituency representatives including fishermen, environmentalists, and non-governmental organizations (NGOs); international experts; and staff of Councils, Commissions, and state and federal agencies.
The items of discussion in the Review Workshop are as follows:
Independent peer review of the assessment developed during the Data Workshop and Assessment Process. Panelists will review the assessment and document their comments and recommendations in a Summary Report.
Although non-emergency issues not contained in this agenda may come before this group for discussion, those issues may not be the subject of formal action during this meeting. Action will be restricted to those issues specifically identified in this notice and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act, provided the public has been notified of the intent to take final action to address the emergency.
This meeting is accessible to people with disabilities. Requests for auxiliary aids should be directed to the SAFMC office (see
The times and sequence specified in this agenda are subject to change.
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 a meeting of a multistakeholder process on promoting software component transparency on November 6, 2018.
The meeting will be held on November 6, 2018, from 10 a.m. to 4 p.m., Eastern Standard 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:
This National Telecommunications and Information Administration cybersecurity multistakeholder process focuses on promoting software component transparency. 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. Although the majority of libraries and components do not have known vulnerabilities, the sheer quantity of software means that some software products ship with vulnerable or out-of-date components.
Under the multistakeholder process, NTIA acts as the convener, but stakeholders drive the outcomes, determine how to scope and organize the work through subgroups or other means, and evaluate success of the process based on the extent to which the group's findings on software component transparency are implemented across the ecosystem. The first meeting of this multistakeholder process was held on July 19, 2018, in Washington, DC.
The main objectives of the November 6, 2018, meeting are to share progress from the working groups and hear feedback from the broader stakeholder community. Stakeholders will also discuss how the outputs of the different work streams can complement each other, and identify issues for further study. More information about stakeholders' work is 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
Defense Acquisition Regulations System, Department of Defense (DoD).
Notice and request for comments regarding a proposed extension of an approved information collection requirement.
In compliance with the Paperwork Reduction Act of 1995, DoD announces the proposed extension of a public information collection requirement and seeks public comment on the provisions thereof.
DoD will consider all comments received by December 21, 2018.
You may submit comments, identified by OMB Control Number 0704-0321, using any of the following methods:
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Comments received generally will be posted without change to
Mr. Mark Gomersall, at 571-372-6099.
This information collection includes requirements relating to DFARS part 232, Contract Financing, and the related clause at DFARS 252.232-7002, Progress Payments for Foreign Military Sales Acquisitions. DFARS 232.502-4-70(a) prescribes use of the clause at DFARS 252.232-7002 in any contract that provides for progress payments and contains FMS requirements. The clause at 252.232-7002 requires each contractor whose contract includes FMS requirements to submit a separate progress payment request for each progress payment rate and to submit a supporting schedule that distinguishes the contract's FMS requirements from U.S. requirements.
Federal Student Aid (FSA), Department of Education (ED).
Notice.
In accordance with the Paperwork Reduction Act of 1995, ED is proposing an extension of an existing information collection.
Interested persons are invited to submit comments on or before November 21, 2018.
To access and review all the documents related to the information collection listed in this notice, please use
For specific questions related to collection activities, please contact Ian Foss, 202-377-3681.
The Department of Education (ED), in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. ED is soliciting comments on the proposed information collection request (ICR) that is described below. The Department of Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.
Federal Student Aid (FSA), Department of Education (ED).
Notice.
In accordance with the Paperwork Reduction Act of 1995, ED is proposing a revision of an existing information collection.
Interested persons are invited to submit comments on or before November 21, 2018.
To access and review all the documents related to the information collection listed in this notice, please use
For specific questions related to collection activities, please contact Ian Foss, 202-377-3681.
The Department of Education (ED), in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. ED is soliciting comments on the proposed information collection request (ICR) that is described below. The Department of Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.
Office of Energy Efficiency and Renewable Energy, Department of Energy.
Notice of open meeting.
This notice announces a meeting of the State Energy Advisory Board (STEAB). The Federal Advisory Committee Act requires that public notice of these meetings be announced in the
The meeting will be held at the National Renewable Energy Laboratory, 15013 Denver West Parkway, Golden, CO 80401.
Michael Li, Senior Policy Advisor, Office of Energy Efficiency and Renewable Energy, U.S. Department of Energy, 1000 Independence Ave. SW, Washington, DC 20585. Phone number 202-287-5189, and email
Office of Environmental Management, Department of Energy.
Notice of open meeting.
This notice announces a meeting of the Environmental Management Site-Specific Advisory Board (EM SSAB), Nevada. The Federal Advisory Committee Act requires that public notice of this meeting be announced in the
Wednesday, November 7, 2018 4 p.m.
Frank H. Rogers Science and Technology Building, 755 East Flamingo, Las Vegas, Nevada 89119.
Barbara Ulmer, Board Administrator, 232 Energy Way, M/S 167, North Las Vegas, Nevada 89030. Phone: (702) 523-0894; Fax (702) 295-2025 or Email:
Office of Environmental Management, Department of Energy.
Notice of open meeting.
This notice announces a meeting of the Environmental Management Site-Specific Advisory Board (EM SSAB), Northern New Mexico. The Federal Advisory Committee Act requires that public notice of this meeting be announced in the
Wednesday, November 7, 2018, 1 p.m.-5:15 p.m.
The Lodge at Santa Fe, Kachina Ballroom, 750 North St. Francis Drive, Santa Fe, New Mexico 87501.
Menice Santistevan, Northern New Mexico Citizens' Advisory Board (NNMCAB), 94 Cities of Gold Road, Santa Fe, NM 87506. Phone (505) 995-0393; Fax (505) 989-1752 or Email:
As announced in a Notice of Technical Conference issued on September 10, 2018, Federal Energy Regulatory Commission (Commission) staff will hold a technical conference, after the October 2018 Commission public meeting, to hear from the Regional Transmission Organizations (RTOs) and Independent System Operators (ISOs)
The agenda for this technical conference is attached.
All interested persons may attend the conference, and registration is not required. However, in-person attendees are encouraged to register on-line at:
This technical conference will be transcribed and webcast. Transcripts will be available immediately for a fee from Ace Reporting (202-347-3700). A link to the webcast of this event will be available in the Commission Calendar of Events at
While this conference is not for the purpose of discussing specific cases, it may address matters at issue in the following Commission proceedings that are pending:
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Commission conferences are accessible under section 508 of the Rehabilitation Act of 1973. For accessibility accommodations please send an email to
For more information about this technical conference, please contact David Rosner at 202-502-8479,
Take notice that the following hydroelectric application has been filed with the Commission and is available for public inspection:
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The Commission strongly encourages electronic filing. Please file comments, motions to intervene, and protests using the Commission's eFiling system at
The Commission's Rules of Practice and Procedure require all intervenors filing documents with the Commission to serve a copy of that document on each person whose name appears on the official service list for the project. Further, if an intervenor files comments or documents with the Commission relating to the merits of an issue that may affect the responsibilities of a particular resource agency, they must also serve a copy of the document on that resource agency.
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m. Individuals desiring to be included on the Commission's mailing list should so indicate by writing to the Secretary of the Commission.
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Take notice that the Commission received the following electric corporate filings:
Take notice that the Commission received the following electric rate filings:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
This constitutes notice, in accordance with 18 CFR 385.2201(b), of the receipt of prohibited and exempt off-the-record communications.
Order No. 607 (64 FR 51222, September 22, 1999) requires Commission decisional employees, who make or receive a prohibited or exempt off-the-record communication relevant to the merits of a contested proceeding, to deliver to the Secretary of the Commission, a copy of the communication, if written, or a summary of the substance of any oral communication.
Prohibited communications are included in a public, non-decisional file associated with, but not a part of, the decisional record of the proceeding. Unless the Commission determines that the prohibited communication and any responses thereto should become a part of the decisional record, the prohibited off-the-record communication will not be considered by the Commission in reaching its decision. Parties to a proceeding may seek the opportunity to respond to any facts or contentions made in a prohibited off-the-record communication, and may request that the Commission place the prohibited communication and responses thereto in the decisional record. The Commission will grant such a request only when it determines that fairness so requires. Any person identified below as having made a prohibited off-the-record communication shall serve the document on all parties listed on the official service list for the applicable proceeding in accordance with Rule 2010, 18 CFR 385.2010.
Exempt off-the-record communications are included in the decisional record of the proceeding, unless the communication was with a cooperating agency as described by 40 CFR 1501.6, made under 18 CFR 385.2201(e)(1)(v).7
The following is a list of off-the-record communications recently received by the Secretary of the Commission. The communications listed are grouped by docket numbers in ascending order. These filings are available for electronic review at the Commission in the Public Reference Room or may be viewed on the Commission's website at
Take notice that the Commission has received the following Natural Gas Pipeline Rate and Refund Report filings:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
Take notice that on October 12, 2018, pursuant to sections 206, 306, and 309 of the Federal Power Act, 16 U.S.C. 824e, 825e, and 825h and Rule 206 of the Federal Energy Regulatory Commission's (Commission) Rules of Practice and Procedure, 18 CFR 385.206, the City of Alexandria, Louisiana (Complainant) filed a formal complaint against Cleco Power LLC (Respondent), alleging that the Respondent is violating its Attachment O formula rate in the Midcontinent Independent System Operator, Inc. Tariff. Complainant also argues that the Respondent is violating Commission orders, regulations, and generally applicable ratemaking policies, all as more fully explained in the complaint.
The Complainant certifies that copies of the complaint were served on the contacts for Respondent and the Louisiana Public Service Commission as listed on the Commission's list of Corporate Officials.
Any person desiring to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211, 385.214). Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate. The Respondent's answer and all interventions, or protests must be filed on or before the comment date. The Respondent's answer, motions to intervene, and protests must be served on the Complainants.
The Commission encourages electronic submission of protests and interventions in lieu of paper using the “eFiling” link at
This filing is accessible on-line at
This is a supplemental notice in the above-referenced proceeding of Birdsboro Power 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 November 5, 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 meeting.
Pursuant to the Federal Advisory Committee Act, the Environmental Protection Agency's (EPA's), Mobile Sources Technical Review Subcommittee (MSTRS) will meet on January 10, 2019. The MSTRS is a subcommittee under the Clean Air Act Advisory Committee. This is an open meeting. The meeting will include discussion of current topics and presentations about activities being conducted by EPA's Office of Transportation and Air Quality. The preliminary agenda for the meeting and any notices about change in venue will be posted on the subcommittee's website:
The meeting will be held on Thursday, January 10, 2019, from 9 a.m. to 4:30 p.m.. Registration begins at 8:30 a.m.
The meeting is currently scheduled to be held at Dupont Circle Hotel, 1500 New Hampshire Ave. NW, Washington DC 20036. However, this date and location are subject to change and interested parties should monitor the subcommittee website (above) for the latest logistical information.
Ms. Courtney McCubbin, Designated Federal Officer, Transportation and Climate Division, Mailcode 6406A, U.S. EPA, 1200 Pennsylvania Ave. NW, Washington, DC 20460; telephone number: 202-564-2436; email:
Background on the work of the subcommittee is available at:
Individuals or organizations wishing to provide comments to the subcommittee should submit them to Ms. McCubbin at the address above by December 27, 2018. The subcommittee expects that public statements presented at its meetings will not be repetitive of previously submitted oral or written statements.
During the meeting, the subcommittee may also hear progress reports from some of its workgroups as well as updates and announcements on activities of general interest to attendees.
Environmental Protection Agency (EPA).
Notice.
EPA is required under the Toxic Substances Control Act (TSCA), as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act, to make information publicly available and to publish information in the
Comments identified by the specific case number provided in this document must be received on or before November 21, 2018.
Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2018-0406, and the specific case number for the chemical substance related to your comment, by one of the following methods:
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Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at
This document provides the receipt and status reports for the period from July 1, 2018 to July 31, 2018. The Agency is providing notice of receipt of PMNs, SNUNs and MCANs (including amended notices and test information); an exemption application under 40 CFR part 725 (Biotech exemption); TMEs, both pending and/or concluded; NOCs to manufacture a new chemical substance; and a periodic status report on new chemical substances that are currently under EPA review or have recently concluded review.
EPA is also providing information on its website about cases reviewed under the amended TSCA, including the section 5 PMN/SNUN/MCAN and exemption notices received, the date of receipt, the final EPA determination on the notice, and the effective date of EPA's determination for PMN/SNUN/MCAN notices on its website at:
Under the Toxic Substances Control Act (TSCA), 15 U.S.C. 2601
Any person who intends to manufacture (including import) a new chemical substance for a non-exempt commercial purpose, or to manufacture or process a chemical substance in a non-exempt manner for a use that EPA has determined is a significant new use, is required by TSCA section 5 to provide EPA with a PMN, MCAN or SNUN, as appropriate, before initiating the activity. EPA will review the notice, make a risk determination on the chemical substance or significant new use, and take appropriate action as described in TSCA section 5(a)(3).
TSCA section 5(h)(1) authorizes EPA to allow persons, upon application and under appropriate restrictions, to manufacture or process a new chemical substance, or a chemical substance subject to a significant new use rule (SNUR) issued under TSCA section 5(a)(2), for “test marketing” purposes, upon a showing that the manufacture, processing, distribution in commerce, use, and disposal of the chemical will not present an unreasonable risk of injury to health or the environment. This is referred to as a test marketing exemption, or TME. For more information about the requirements applicable to a new chemical go to:
Under TSCA sections 5 and 8 and EPA regulations, EPA is required to publish in the
This action provides information that is directed to the public in general.
No.
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In the past, EPA has published individual notices reflecting the status of TSCA section 5 filings received, pending or concluded. In 1995, the Agency modified its approach and streamlined the information published in the
For the PMN/SNUN/MCANs received by EPA during this period, Table I provides the following information (to the extent that such information is not subject to a CBI claim) on the notices received by EPA during this period: The EPA case number assigned to the notice that indicates whether the submission is an initial submission, or an amendment, a notation of which version was received, the date the notice was received by EPA, the submitting manufacturer (
As used in each of the tables in this unit, (S) indicates that the information in the table is the specific information provided by the submitter, and (G) indicates that this information in the table is generic information because the specific information provided by the submitter was claimed as CBI. Submissions which are initial submissions will not have a letter following the case number. Submissions which are amendments to previous submissions will have a case number followed by the letter “A” (
In Table II. of this unit, EPA provides the following information (to the extent that such information is not claimed as CBI) on the TMEs received by EPA during this period: The EPA case number assigned to the TME, the date the TME was received by EPA, the projected end date for EPA's review of the TME, the submitting manufacturer/importer, the potential uses identified by the manufacturer/importer in the TME, and the chemical identity.
In Table III. of this unit, EPA provides the following information (to the extent that such information is not claimed as CBI) on the NOCs received by EPA during this period: The EPA case number assigned to the NOC including whether the submission was an initial or amended submission, the date the NOC was received by EPA, the date of commencement provided by the submitter in the NOC, a notation of the type of amendment (
In Table IV. of this unit, EPA provides the following information (to the extent such information is not subject to a CBI claim) on the test information received by EPA during this time period: The EPA case number assigned to the test information; the date the test information was received by EPA, the type of test information submitted, and chemical substance identity.
If you are interested in information that is not included in these tables, you may contact EPA's technical information contact or general information contact as described under
15 U.S.C. 2601
Thursday, October 25, 2018 at 10:00 a.m.
1050 First Street NE, Washington, DC (12th Floor).
This meeting will be open to the public.
Judith Ingram, Press Officer, Telephone: (202) 694-1220.
Individuals who plan to attend and require special assistance, such as sign language interpretation or other reasonable accommodations, should contact Dayna C. Brown, Secretary and Clerk, at (202) 694-1040, at least 72 hours prior to the meeting date.
Board of Governors of the Federal Reserve System.
Notice, request for comment.
The Board of Governors of the Federal Reserve System (Board) invites comment on a proposal to extend for three years, without revision, the Basel II Interagency Pillar 2 Supervisory Guidance (Pillar 2 Guidance) (FR 4199; OMB No. 7100-0320).
Comments must be submitted on or before December 21, 2018.
You may submit comments, identified by
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Additionally, commenters may send a copy of their comments to the OMB Desk Officer—Shagufta Ahmed—Office of Information and Regulatory Affairs, Office of Management and Budget, New Executive Office Building, Room 10235, 725 17th Street NW, Washington, DC 20503, or by fax to (202) 395-6974.
A copy of the PRA OMB submission, including the proposed reporting form and instructions, supporting statement, and other documentation will be placed into OMB's public docket files, if approved. These documents will also be made available on the Board's public website at:
Federal Reserve Board Clearance Officer—Nuha Elmaghrabi—Office of the Chief Data Officer, Board of Governors of the Federal Reserve System, Washington, DC 20551, (202) 452-3829. Telecommunications Device for the Deaf (TDD) users may contact (202) 263-4869, Board of Governors of the Federal Reserve System, Washington, DC 20551.
On June 15, 1984, the Office of Management and Budget (OMB) delegated to the Board authority under the Paperwork Reduction Act (PRA) to approve and assign OMB control numbers to collection of information requests and requirements conducted or sponsored by the Board. In exercising this delegated authority, the Board is directed to take every reasonable step to solicit comment. In determining whether to approve a collection of information, the Board will consider all comments received from the public and other agencies.
The Board invites public comment on the following information collection, which is being reviewed under authority delegated by the OMB under the PRA. Comments are invited on the following:
a. Whether the proposed collection of information is necessary for the proper performance of the Board's functions, including whether the information has practical utility;
b. The accuracy of the Board's estimate of the burden of the proposed information collection, including the validity of the methodology and assumptions used;
c. Ways to enhance the quality, utility, and clarity of the information to be collected;
d. Ways to minimize the burden of information collection on respondents, including through the use of automated collection techniques or other forms of information technology; and
e. Estimates of capital or startup costs and costs of operation, maintenance, and purchase of services to provide information.
A bank is required to comply with the advanced approaches framework if it meets either of two independent threshold criteria: (1) Consolidated total assets of $250 billion or more, as reported on the most recent year-end regulatory reports; or (2) consolidated total on-balance sheet foreign exposure of $10 billion or more at the most recent year-end.
A BHC is required to comply with the advanced approaches framework if the BHC has (1) consolidated total assets (excluding assets held by an insurance underwriting subsidiary) of $250 billion or more, as reported on the most recent year-end regulatory reports; (2) consolidated total on-balance sheet foreign exposure of $10 billion or more at the most recent year-end; or (3) a subsidiary depository institution (DI) that meets the criteria to be subject to the advanced approaches rule or elects to adopt the advanced approaches. As of year-end 2017, 13 BHCs meet the above criteria and are therefore subject to the advanced approaches rule.
Also, some banks or BHCs may voluntarily decide to adopt the advanced approaches framework. Both mandatory and voluntary respondents are required to meet certain qualification requirements before they can use the advanced approaches framework for risk-based capital purposes.
The Pillar 2 Guidance sets the expectation that respondents maintain certain documentation as described in paragraphs 37, 41, 43, and 46 of this portion of the guidance. Details of the expectations for each section are provided below.
Because the collections of information associated with the FR 4199 do not involve the submission of information to the Board, no issues of confidentiality would normally arise. To the extent that the Board collects information kept by a banking organization as a record during an examination of the banking organization, confidential treatment may be afforded to the records under exemption 8 of the Freedom of Information Act (FOIA) (5 U.S.C. 552(b)(8)), which protects information collected as part of the Board's supervisory process. Additionally, individual respondents may request that certain information be afforded confidential treatment pursuant to exemption 4 of FOIA (5 U.S.C. 552(b)(4)) if the information has not previously been publically disclosed and the release of the data would likely cause substantial harm to the competitive position of the respondent.
Office of Acquisition Policy, General Services Administration (GSA).
Notice of request for comments regarding the extension of a previously existing OMB clearance.
Under the provisions of the Paperwork Reduction Act, the General Services Administration will be submitting to the Office of Management and Budget (OMB) a request to review and approve an extension of a previously approved information collection requirement regarding Environmental Conservation, Occupational Safety, and Drug-Free Workplace.
Submit comments on or before: November 21, 2018.
Submit comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to: Office of Information and Regulatory Affairs of OMB, Attention: Desk Officer for GSA, Room 10236, NEOB, Washington, DC 20503. Additionally submit a copy to GSA by any of the following methods:
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Ms. Johnnie McDowell, Procurement Analyst, General Services Acquisition Policy Division, GSA, at telephone 202-718-6112, or via email to
The Federal Hazardous Substance Act and Hazardous Material Transportation Act prescribe standards for packaging of hazardous substances. To meet the requirements of the Acts, the General Services Administration Regulation prescribes provision 552.223-72, Hazardous Material Information, to be inserted in solicitations and contracts that provides for delivery of hazardous materials on a Free On Board (FOB) origin basis.
This information collection will be accomplished by means of the provision which requires the contractor to identify for each National Stock Number (NSN), the DOT Shipping Name, Department of Transportation (DOT) Hazards Class, and whether the item requires a DOT label. Contracting Officers and technical personnel use the information to monitor and ensure contract requirements based on law and regulation.
Properly identified and labeled items of hazardous material allows for appropriate handling of such items throughout GSA's supply chain system. The information is used by GSA, stored in an NSN database and provided to GSA customers. Non-Collection and/or a less frequently conducted collection of the information resulting from GSAR provision 552.223-72 would prevent the Government from being properly notified. Government activities may be hindered from apprising their employees of; (1) All hazards to which they may be exposed; (2) Relative symptoms and appropriate emergency treatment; and (3) Proper conditions and precautions for safe use and exposure.
A 60-day notice published in the
Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).
Notice of meeting.
In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Board of Scientific Counselors, National Center for Health Statistics (BSC, NCHS). This meeting is open to the public; however, visitors must be processed in accordance with established federal policies and procedures. For foreign nationals or non-U.S. citizens, pre-approval is required (please contact Gwen Mustaf, 301-458-4500,
The meeting will be held on December 4, 2018, 11:00 a.m.-5:30 p.m., EDT, and December 5, 2018, 8:30 a.m.-1:00 p.m., EDT.
NCHS Headquarters, 3311 Toledo Road, Hyattsville, Maryland 20782.
Sayeedha Uddin, M.D., M.P.H., Executive Secretary, NCHS/CDC, Board of Scientific Counselors, 3311 Toledo Road, Room 2627, Hyattsville, Maryland 20782, telephone (301)458-4303, email
The Chief Operating Officer, Centers for Disease Control and Prevention, has been delegated the authority to sign
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 CDC Worksite Health Scorecard, an updated organizational assessment and planning tool designed to help employers identify gaps in their health promotion programs and prioritize high-impact strategies for health promotion at their worksites.
CDC must receive written comments on or before December 21, 2018.
You may submit comments, identified by Docket No. CDC-2018-0096 by any of the following methods:
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To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact Jeffrey 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.
CDC Worksite Health ScoreCard—Revision—(OMB# 0920-1014 Exp. 02/28/2019) National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC).
In the United States, chronic diseases such as heart disease, obesity and diabetes are among the leading causes of death and disability. Although chronic diseases are among the most common and costly health problems, they are also among the most preventable. Adopting healthy behaviors—such as eating nutritious foods, being physically active and avoiding tobacco use—can prevent the devastating effects and reduce the rates of these diseases.
Employers are recognizing the role they can play in creating healthy work environments and providing employees with opportunities to make healthy lifestyle choices. To support these efforts, the Centers for Disease Control and Prevention (CDC) developed an online organizational assessment tool called the CDC Worksite Health Scorecard (“Scorecard”).
The Scorecard is a tool designed to help employers assess whether they have implemented evidence-based health promotion interventions or strategies in their worksites to prevent heart disease, stroke, and related conditions such as hypertension, diabetes, and obesity. The updated, validated, and pilot tested instrument contains 154 core health topic yes/no questions, eight core worksite demographic questions, with an additional eight optional worksite demographic questions divided into 19 modules (risk factors/conditions/demographics) that assess how evidence-based health promotion strategies are implemented at a worksite. These strategies include health promoting counseling services, environmental supports, policies, health plan benefits, and other worksite programs shown to be effective in preventing heart disease, stroke, and related health conditions. Employers can use this tool to assess how a comprehensive health promotion and disease prevention program is offered to their employees, to help identify program gaps, and to prioritize high impact strategies for health promotion at the worksite.
This is a revised Information Collection Request (ICR) supporting a broader group of employers to access the updated and pilot tested Scorecard, a web-based worksite organizational assessment, to regularly assess their workplace health programs and practices. Scorecard users will create a user account, complete the online assessment and receive an immediate feedback report that summarizes the current status of their worksite health program; identifies gaps in current programming; benchmarks individual employer results against other users of the system; and provides access to worksite health tools and resources to address employer gaps and priority program areas.
The updated Scorecard is based on a 2017 pilot test to determine the validity and reliability involving 89 employers (each represented by two knowledgeable employees) who completed the survey and follow-up telephone interviews to gather general impressions of the Scorecard—particularly the new modules—and also to discuss items where there were discrepancies (and items that were left blank) to understand the respondent's interpretation and perspective of their answers to these questions. The revised instrument includes some reorganization of the instrument and minor revisions, particularly to the new modules/questions, to better explain and define the context, concepts, or administration of the strategies and interventions contained in the questions has been completed. This will streamline future information collection and minimize additional response time.
CDC will continue to provide outreach to, and register approximately 800 employers per year to use the online Scorecard survey in their workplace health program assessment, planning, and implementation efforts, which is open to employers of all sizes, industry sectors, and geographic locations across the country. OMB approval is requested for three years. Participation is voluntary and there are no costs to respondents other than their time.
Department of Health and Human Services (HHS), Centers for Disease Control and Prevention (CDC).
Notice of availability.
On May 31, 2018, the Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) requested comments on a plan to (1) revise the definition and characterization of Assisted Reproductive Technology (ART) success rates and (2) introduce clinic validation footnotes for the annual ART Fertility Clinic Success Rates Report. In the plan, CDC proposed to include the footnotes to identify clinics selected by CDC to participate in the validation process of the National ART Surveillance System (NASS) data and: (a) Do participate, (b) do participate and have major data discrepancies identified through this process, or (c) decline to participate in the data validation process. This notice responds to the comments received in response to the notice published on May 31, 2018 and announces the availability of the revised process for ART Success Rates Reporting and plans for revising Data Validation Procedures.
Jeani Chang, Division of Reproductive Health, National Center for Chronic Disease Prevention and Health Promotion, Centers for Disease Control and Prevention, 4770 Buford Highway NE, Mailstop F-74, Atlanta, Georgia 30341. Telephone: (770) 488-5200; email:
CDC received three public comments to the docket. One comment was considered nonsubstantive because it was outside the scope of the docket. A second comment was supportive of CDC's planned approach for revising the definition of success rates and introducing clinic validation footnotes. The third comment contained concerns about CDC's planned clinic validation footnotes and the approach to clinic validation, and requested a clarification of the reporting requirements of embryo banking cycles. These suggestions, as well as CDC's responses, are included below:
Section 2(a) of Public Law 102-493 (42 U.S.C. 263a-1(a)), the Fertility Clinic Success Rate and Certification Act of 1992 (FCSRCA), requires that each assisted reproductive technology (ART) program report annually to the Secretary of the Department of Health and Human Services through the Centers for Disease Control and Prevention (CDC) pregnancy success rates achieved through assisted reproductive technology. The FCSRCA also requires CDC to annually publish and distribute to the public reported pregnancy success rates for each ART clinic. According to the FCSRCA, the definitions of pregnancy success rates should be developed in consultation with appropriate consumer and professional organizations, should take into account the effect on success rates of age, diagnosis, and other significant factors, and should include the live birth rate per attempted ovarian stimulation procedure and the live birth rate per successful oocyte retrieval.
Specifics about the reporting process and requirements are described in “Reporting of Pregnancy Success Rates from Assisted Reproductive Technology (ART) Programs” (August 26, 2015; 80 FR (51811-51819)). Specifics about the definition and characterization of ART success rates were last described in “Reporting of Pregnancy Success Rates from Assisted Reproductive Technology Programs” (February 5, 2004; 69 FR (5548-5550)). Success rates for fresh, nondonor cycles were defined as: 1. The rate of pregnancy after completion of ART according to the number of all ovarian stimulation or monitoring procedures; 2. the rate of live birth after completion of ART according to the number of all ovarian stimulation or monitoring procedures, the number of oocyte retrieval processes, and the number of embryo (or zygote or oocyte) transfer procedures; 3. the rate of singleton live birth after completion of ART according to the number of all ovarian stimulation or monitoring procedures and the number of embryo (or zygote or oocyte) transfer procedures. Success rates for cycles using thawed embryos and cycles using donor oocytes or embryos were defined as: 4. the rate of live birth after completion of ART according to the number of embryo (or zygote or oocyte) transfer procedures; 5. the rate of singleton live birth after completion of ART according to the number of embryo (or zygote or oocyte) transfer procedures.
Effective for reporting year 2017, CDC is implementing substantial changes to the definition and characterization of ART success rates due to changes in clinical practice and more variation in treatment options, including improvements in cryopreservation resulting in more segmentation of typical treatment cycles. The field of ART is moving toward the calculation and reporting of cumulative success rates where data collection systems can collect successes over all embryo transfers from a single oocyte retrieval or across several oocyte retrievals and embryo transfers. After consultation with consumer and professional organizations with expertise in ART, CDC will begin cumulative ART success rates reporting in reporting year 2017. The ART success rates described in this
ART success rates for ART procedures among all patients using their own eggs are defined as:
1. The rate of live birth or singleton live birth resulting from the transfer of oocytes retrieved from the patient in the year prior to the reporting year or from the transfer of embryos created from oocytes retrieved from the patient in the year prior to the reporting year. For the purpose of this definition, transfer procedures must have started within 12 months of the start of the retrieval procedure. Oocytes must have been retrieved in the year prior to the reporting year in order to allow a full year to perform transfers of the retrieved oocytes (either in the prior reporting year or in the current reporting year). The live birth rate and singleton live birth rate will be presented according to the number of:
a. All ovarian stimulation or monitoring procedures started from the year prior to the reporting year with the intent to retrieve oocytes from the patient.
b. All ovarian stimulation or monitoring procedures started in the year prior to the reporting year with the intent to retrieve oocytes from the patient in which at least one oocyte was retrieved.
c. All transfer procedures of at least one oocyte retrieved from the patient in the year prior to the reporting year, or of at least one embryo created from an oocyte retrieved from the patient in the year prior to the reporting year. For the purpose of this definition, egg or embryo transfer procedures must have started within 12 months of the start of the retrieval procedure.
2. The number of ovarian stimulation or monitoring procedures started in the year prior to the reporting year with the intent to retrieve oocytes from the patient presented according to the number of:
a. Live births resulting from all transfers of at least one oocyte retrieved from the patient in the year prior to the reporting year, or transfers of at least one embryo created from an oocyte retrieved from the patient in the year prior to the reporting year. For the purpose of this definition, egg or embryo transfer procedures must have started within 12 months of the start of the retrieval procedure.
Other rates for ART procedures among all patients using their own eggs are defined as follows (and may be provided publically at the ART program's discretion)—
3. The rate of cancellation, implantation, pregnancy, live birth,
a. All ovarian stimulation or monitoring procedures started in the year prior to the reporting year with the intent to retrieve oocytes from the patient.
b. All ovarian stimulation or monitoring procedures started in the year prior to the reporting year with the intent to retrieve oocytes from the patient in which at least one oocyte was retrieved.
c. All transfer procedures of at least one oocyte retrieved from the patient in the year prior to the reporting year, or of at least one embryo created from an oocyte retrieved from the patient in the year prior to the reporting year. For the purpose of this definition, egg or embryo transfer procedures must have started within 12 months of the start of the retrieval procedure.
d. All first, second, third, or more transfer procedures after retrieval of at least one oocyte from the patient in the year prior to the reporting year, or of at least one embryo created from an oocyte retrieved from the patient in the year prior to the reporting year. For the purpose of this definition, egg or embryo transfer procedures must have started within 12 months of the start of the retrieval procedure.
Rates for ART procedures among new ART patients (
4. The rate of live birth resulting from the transfer of oocytes or embryos from all first intended oocyte retrievals presented according to the number of:
a. ART patients who reported at the start of the retrieval procedure that they had no prior ART stimulations and no prior frozen ART procedures. For the purpose of this definition, the retrieval procedure must have started in the year prior to the reporting year.
5. The rate of live birth resulting from the transfer of oocytes or embryos from all first or second intended oocyte retrievals presented according to the number of:
a. ART patients who reported at the start of the retrieval procedure that they had no prior ART stimulations and no prior frozen ART procedures. For the purpose of this definition, the retrieval procedure must have started in the year prior to the reporting year.
6. The rate of live birth resulting from the transfer of oocytes or embryos from all intended oocyte retrievals presented according to the number of:
a. ART patients who reported at the start of the retrieval procedure that they had no prior ART stimulations and no prior frozen ART procedures. For the purpose of this definition, the retrieval procedure must have started in the year prior to the reporting year.
7. The number of ovarian stimulation or monitoring procedures started in the year prior to the reporting year with the intent to retrieve oocytes from the patient presented according to the number of:
a. ART patients who reported at the start of the retrieval procedure that they had no prior ART stimulations and no prior frozen ART procedures.
8. The number of transfer procedures of at least one oocyte retrieved from the patient in the year prior to the reporting year, or of at least one embryo created from an oocyte retrieved from the patient in the year prior to the reporting year presented according to the number of:
a. Ovarian stimulation or monitoring procedures started in the year prior to the reporting year with the intent to retrieve oocytes from the patient. For the purpose of this definition, egg or embryo transfer procedures must have started within 12 months of the start of the retrieval procedure. Also, ART patients must have reported at the start of the retrieval procedure that they had no prior ART stimulations and no prior frozen ART procedures.
Success rates for ART procedures among patients using oocytes or embryos from a donor are defined as—
9. The rate of live birth or singleton live birth presented according to the number of:
a. Transfer procedures of at least one donor egg, embryo created from a donor egg, or donated embryo started in the current reporting year.
Other rates for ART procedures among patients using oocytes or embryos from a donor are defined as follows (and may be provided publically at the ART program's discretion):
10. The rate of cancellation, implantation, pregnancy, live birth, singleton live birth, multiple live birth, twin live birth, triplet or higher order live birth, preterm live birth, low birthweight live birth, or term, normal birthweight and singleton live birth presented according to the number of:
a. ART procedures to prepare a patient (recipient) for the transfer of at least one donor egg, embryo created from a donor egg, or donated embryo, started in the current reporting year.
b. Transfer procedures of at least one donor egg, embryo created from a donor egg, or donated embryo started in the current reporting year.
At the discretion of the ART program, ART reporting also may include:
11. The number, average number or percentage of ART procedures or ART patients with certain characteristics, such as:
a. Patient characteristics (
b. ART procedure characteristics (
All ART patient and procedure characteristics, ART success rates, and other rates for patients using their own oocytes as well as for patients using oocytes or embryos from a donor may be stratified by CDC by factors thought to influence the outcome of an ART procedure.
12. Factors for stratification may include:
a. Characteristics of the ART patient such as patient age or reason for ART.
b. Characteristics of the ART procedure such as type of treatment (fertility preservation, short term banking, in vitro fertilization, gamete intrafallopian transfer, zygote intrafallopian transfer), stimulation protocol, the source of the oocytes or embryos (patient or donor), the state of the oocytes or embryos (fresh or frozen), the intent of the procedure, the use of prenatal genetic diagnosis or screening, the use of intracytoplasmic sperm injection, the use of assisted hatching, the use of a gestational carrier, the stage of the embryo at transfer, or the number of embryos transferred.
Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).
Notice of meeting.
In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Mine Safety and Health Research Advisory Committee (MSHRAC). This meeting is open to the public, limited only by the space available. The meeting room accommodates approximately 38 people. If you wish to attend in person or by phone, please contact Marie Chovanec by email at
The meeting will be held on November 29, 2018, 8 a.m.-4 p.m., MST and on November 30, 2018, 8 a.m.-12 p.m. MST.
University of Arizona, ENR2 Building, Room S215, 1064 E. Lowell Street, Tucson, AZ 85721 United States.
Jeffrey H. Welsh, Designated Federal Officer, MSHRAC, NIOSH, CDC, 626 Cochrans Mill Road, Pittsburgh, PA 15236, telephone 412-386-4040; email
The Chief Operating Officer, Centers for Disease Control and Prevention, has been delegated the authority to sign
In accordance with the Paperwork Reduction Act of 1995, the Centers for Disease Control and Prevention (CDC) has submitted the information collection request titled Assessment of Evidence to Inform Standards that Ensure Turnout Gear Remains Protective Throughout Its Lifecycle to the Office of Management and Budget (OMB) for review and approval. CDC previously published a “Proposed Data Collection Submitted for Public Comment and Recommendations” notice on April 12, 2018 to obtain comments from the public and affected agencies. CDC received one comment related to the previous notice. This notice serves to allow an additional 30 days for public and affected agency comments.
CDC will accept all comments for this proposed information collection project. The Office of Management and Budget is particularly interested in comments that:
(a) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(b) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
(c) Enhance the quality, utility, and clarity of the information to be collected;
(d) Minimize the burden of the collection of information on those who are to respond, including, through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
(e) Assess information collection costs.
To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call (404) 639-7570 or send an email to
Evidence to Inform Standards that Ensure Turnout Gear Remains Protective Throughout Its Lifecycle—New—National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention (CDC).
Turnout gear is a type of personal protective equipment used by the 1.1 million U.S. fire fighters to shield the body from carcinogens, flames, heat, and chemical/biological agents. It serves as a barrier to external hazards while simultaneously allowing for the escape of metabolic heat to prevent elevated core body temperatures. To provide the necessary performance characteristics, turnout gear design is complex, consisting of three major layers that work as a composite—a thermal liner, a moisture barrier, and an outer shell.
Consensus standards provide performance requirements and retirement criteria for turnout gear. The retirement criteria is based on visual inspections and a 10-year age cap with visual inspection being less effective for the moisture barrier and thermal liner layers. Recent data of turnout gear donated from fire departments demonstrates that turnout gear from 2 to 10 years old was unable to meet all performance requirements. Thus, under the current retirement criteria, turnout
Intuitively, the use conditions to which turnout gear would be exposed to when used by a large or medium metropolitan fire department would be very different than those of a smaller department. However, the absence of scientific data to link performance to use conditions (
This study will obtain a statistically meaningful sample of turnout gear from three fire departments. The use conditions for the sampled turnout gear will be determined, and the gear will be subjected to established performance requirements. For each set of gear, its performance will be directly linked to its use condition history. This combined lab and field data will help determine if there is a relationship between turnout gear use conditions and the ability for turnout gear to effectively protect the user.
The use conditions for each set of sampled gear will be determined by:
(1) Reviewing fire department records, practices, and policies;
(2) surveying the fire fighters assigned to each set of sampled gear to obtain one-month of retrospective information about the use conditions to which it was likely exposed; and
(3) a 6-month prospective data collection where the fire fighters assigned to each set of sampled gear provide information about their shift-specific exposures.
The estimated annualized Burden Hours for this information collection is 1,050. There is no cost to respondents other than their time.
Food and Drug Administration, HHS.
Notice.
The meeting of the Allergenic Products Advisory Committee scheduled for November 7, 2018, is cancelled. This meeting was announced in the
Serina Hunter-Thomas, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 6338, Silver Spring, MD 20993-0002, 240-402-5771,
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the
Submit either electronic or written comments on the collection of information by December 21, 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 December 21, 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.
In compliance with 44 U.S.C. 3507, FDA will submit to the Office of Management and Budget a request to review and approve a new collection of information: “Collection of Conflict of Interest Information for Participation in FDA Non-Employee Fellowship and Traineeship Programs.” Section 742 (b) of the Food, Drug and Cosmetic Act (21 U.S.C. 379l) allows FDA to conduct and support intramural training programs through fellowship and traineeship programs. These new forms provide the FDA with information about financial investments and relationships from non-employee scientists who participate in FDA fellowship and traineeship programs. Participants in FDA fellowship and traineeship programs will be asked for certain information about financial interests and current relationships: (1) Description of the financial interest; (2) the type of financial interest (
FDA estimates the burden of this collection of information as follows:
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for TECENTRIQ and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.
Anyone with knowledge that any of the dates as published (see the
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 December 21, 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.”
•
Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.
The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human biological products, the testing phase begins when the exemption to permit the clinical investigations of the biological product becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human biological product and continues until FDA grants permission to market the biological product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human biological product will include all the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).
FDA has approved for marketing the human biologic product TECENTRIQ (atezolizumab). TECENTRIQ is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Subsequent to this approval, the USPTO received a patent term restoration application for TECENTRIQ (U.S. Patent No. 8,217,149) from Genentech, Inc., and the USPTO requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated September 20, 2017, FDA advised the USPTO that this human biological product had undergone a regulatory review period and that the approval of TECENTRIQ represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.
FDA has determined that the applicable regulatory review period for TECENTRIQ is 1,836 days. Of this time, 1,708 days occurred during the testing phase of the regulatory review period, while 128 days occurred during the approval phase. These periods of time were derived from the following dates:
1.
2.
3.
This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 769 days of patent term extension.
Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see
Submit petitions electronically to
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for TYMLOS and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department
Anyone with knowledge that any of the dates as published (see the
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 December 21, 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
Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.
The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations of the drug becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).
FDA has approved for marketing the human drug product TYMLOS (abaloparatide). TYMLOS is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture. Subsequent to this approval, the USPTO received patent term restoration applications for TYMLOS (U.S. Patent Nos. 7,803,770; 8,148,333; and 8,748,382) from Radius Health, Inc., and the USPTO requested FDA's assistance in determining the patents' eligibility for patent term
FDA has determined that the applicable regulatory review period for TYMLOS is 4,130 days. Of this time, 3,735 days occurred during the testing phase of the regulatory review period, while 395 days occurred during the approval phase. These periods of time were derived from the following dates:
1.
2.
3.
This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its applications for patent extension, this applicant seeks 724 days, 1,123 days, or 1,128 days of patent term extension.
Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see
Submit petitions electronically to
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA, Agency, or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Fax written comments on the collection of information by November 21, 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.
This information collection supports the above captioned Agency guidance document. The guidance document was issued to help individuals with procedures on formal meetings between FDA and sponsors or applicants regarding the development and review of Prescription Drug User Fee Act (PDUFA) products. The guidance describes procedures for requesting, scheduling, conducting, and documenting such formal meetings. The guidance provides information on how FDA interprets and applies section 119(a) of the Food and Drug Administration Modernization Act of 2007 (Pub. L. 105-115), specific PDUFA goals for the management of meetings associated with the review of human drug applications for PDUFA products, and provisions of existing regulations describing certain meetings (§§ 12.47 and 312.82 (21 CFR 312.47 and 312.82)). The collection of information described in the guidance reflects the current and past practice of sponsors and applicants to submit meeting requests and background information prior to a scheduled meeting. Agency regulations currently permit such requests and recommend the submission of an information package before an “end-of-phase 2 meeting” (§§ 312.47(b)(1)(ii) and (iv)) and a “pre-NDA meeting” (§ 312.47(b)(2)). While the information collection provisions of § 312.47 are currently approved under OMB control number 0910-0014, the guidance provides additional recommendations for submitting information to FDA in support of a meeting request. The guidance document is available on our website at:
We recommend that a request be submitted in this manner to ensure that each request is kept in the administrative file with the complete application, and to ensure that pertinent information about the request is entered into appropriate tracking databases. Using information from our tracking databases enables us to monitor progress on activities attendant to scheduling and holding a formal meeting and to ensure that appropriate steps will be taken in a timely manner.
The guidance recommends that meeting requests include the following information:
We use the information to determine the purpose of the meeting, the necessary participants, the proposed agenda, and to schedule the meeting.
The information package enables Agency staff to prepare for the meeting and allows appropriate time for reviewing relevant product data. Although FDA reviews similar information in the meeting request, the information package should provide updated data reflecting the most current and accurate information available to the sponsor or applicant.
In the
FDA estimates the burden of this collection of information as follows:
Our estimated burden for the information collection reflects an overall increase since the previous OMB approval. We attribute this adjustment to an increase in the number of meeting requests and information packages received over the last few years.
Based on Agency data, we estimate 1,319 sponsors and applicants (respondents) request 3,058 formal meetings with CDER annually, and 301 respondents request 363 formal meetings with CBER annually regarding the development and review of a PDUFA product. The hours per response, which is the estimated number of hours that a respondent spends preparing the information to be submitted with a meeting request in accordance with the guidance, is estimated to be 10 hours. We expect it takes this amount of time to gather and copy brief statements about the product as well as a description of the purpose and details of the meeting.
Also consistent with Agency data, we estimate 1,149 respondents submitted 2,522 information packages to CDER annually, and 187 respondents submitted 210 information packages to CBER annually, prior to a formal meeting regarding the development and review of a PDUFA product. We estimate 18 hours is needed to prepare
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: 050” (Recognition List Number: 050), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.
Submit electronic or written comments concerning this document at any time. These modifications to the list of recognized standards are effective October 22, 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: 050 is available on the internet at
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 (the 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
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: 050” 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: 050.
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.
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the
Submit either electronic or written comments on the collection of information by December 21, 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 December 21, 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
Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733,
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
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.
This information collection supports FDA regulations at 21 CFR part 1, subpart L—Foreign Supplier Verification Programs for Food Importers, as well as associated guidance. As amended by the FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353), the Federal Food, Drug, and Cosmetic Act (FD&C Act) enables the Agency to better protect the public health by helping to ensure the safety and security of the food supply. The regulations are intended to help ensure that food imported into the United States is produced in compliance with specific processes and procedures, including reasonably appropriate risk-based preventive controls. The regulations establish that importers of foods must develop, maintain, and follow an FSVP that provides adequate assurances that a foreign supplier is producing the food in compliance with processes and procedures that provide at least the same level of public health protection as those required under section 418 of the FD&C Act (21 U.S.C. 350g) (regarding hazard analysis and risk-based preventive controls for certain foods) or 419 (21 U.S.C. 350h) (regarding standards for produce safety), if either is applicable, and the implementing regulations, and is producing the food in compliance with sections 402 (21 U.S.C. 342) (regarding adulteration) and 403(w) (21 U.S.C. 343(w)) (if applicable) (regarding misbranding with respect to labeling for the presence of major food allergens) of the FD&C Act. The regulations also provide for certain exemptions.
To assist respondents with the requirements we have developed Agency guidance, which is available at:
We estimate the burden of the information collection is as follows:
We are retaining the currently approved burden estimates. The FSVP requirements became effective May 30, 2017, and we continue to evaluate associated burden.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for BESPONSA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.
Anyone with knowledge that any of the dates as published (see the
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 December 21, 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
Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.
The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human biological products, the testing phase begins when the exemption to permit the clinical investigations of the biological product becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human biological product and continues until FDA grants permission to market the biological product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human biological product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).
FDA has approved for marketing the human biologic product BESPONSA (inotuzumab ozogamicin). BESPONSA is indicated for treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia. Subsequent to this approval, the USPTO received patent term restoration applications for BESPONSA (U.S. Patent Nos. 8,153,768; 8,835,611; and 8,747,857) from Wyeth Holdings LLC, and the USPTO requested FDA's assistance in determining the patents' eligibility for patent term restoration. In a letter dated April 4, 2018, FDA advised the USPTO that this human biological product had undergone a regulatory review period and that the approval of BESPONSA represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.
FDA has determined that the applicable regulatory review period for BESPONSA is 5,298 days. Of this time, 5,057 days occurred during the testing phase of the regulatory review period, while 241 days occurred during the approval phase. These periods of time were derived from the following dates:
1.
2.
3.
This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its applications for patent extension, this applicant seeks 654 days, 703 days, or 1,099 days of patent term extension.
Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see
Submit petitions electronically to
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA, or Agency) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Fax written comments on the collection of information by November 21, 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.
The draft guidance document provides establishments that collect blood and blood components for transfusion with recommendations for labeling RBC units with non-ABO/Rh(D) antigen typing results obtained from previous donations (historical antigen typing results). The draft guidance provides recommendations to transfusion services for managing RBC units labeled with historical antigen typing results. The guidance also provides licensed blood collection establishments that choose to implement labeling of RBC units with historical antigen typing results instructions regarding how to report the manufacturing and labeling changes under 21 CFR 601.12.
The guidance also recommends establishments that collect blood and blood components for transfusion should convey to transfusion services the practices for repeating historical RBC typing results on current donations and for labeling RBC units with historical RBC antigen typing results.
We believe that collection establishments have already developed standard operating procedures for including the non-ABO/Rh(D) historical antigen typing results on a tie-tag or directly on the container label, and for conveying any change in their antigen typing or labeling practices to their consignees, including practices for repeating historical RBC typing results on current donations and for labeling RBC units with historical RBC antigen typing results.
In the
The draft guidance also refers to previously approved collections of information found in FDA regulations. The collections of information in 21 CFR 601.12 have been approved under OMB control number 0910-0338; and the collections of information in 21 CFR
Pursuant to the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) announces the following advisory committee hearing.
In its capacity to advise the HHS Secretary on health data, statistics, privacy, national health information policy, and HIPAA, NCVHS is in the final stages of the development of a standards update and adoption roadmap, referred to as the Predictability Roadmap. The development of the Predictability Roadmap has been a year and a half long process, achieved in collaboration with industry stakeholders and the standards development organizations (SDOs). The overall vision for the Predictability Roadmap is that:
• HIPAA covered entities and their business associates use the adopted standards and operating rules in a consistent way to exchange health information and conduct business; and
• Standards are reliably updated and adopted so that covered entities know when they will need to, and/or be able to update systems and business processes.
To accomplish this goal, NCVHS conducted several information gathering activities and stakeholder engagement meetings and workshops: In June 2017 the Subcommittee on Standards met with each of the standards development organizations (SDOs) to learn about their individual maintenance processes; in August 2017 the Subcommittee held a visioning exercise with the SDOs and Designated Standards Maintenance Organization (DSMO); and in May 2018, the Subcommittee conducted a CIO Forum with 21 health care technology experts and senior corporate officers representing a cross-section of organizations that were end-users of the HIPAA and ACA administrative standards. The goal of this Forum was to elicit input for improving the standards development, update and adoption process, and address barriers to use of those standards. Based on this work, the Subcommittee on Standards developed a draft Predictability Roadmap comprised of 23 recommendations organized under three major focus areas. The draft recommendations were presented at the September 13-14 NCVHS meeting and are posted on the website at:
The purpose of this Subcommittee hearing is to obtain input from stakeholders on the draft recommendations designed to improve the processes for updating, adopting and using standards and operating rules, and developing a formal Predictability Roadmap. The Subcommittee will use the feedback received at this hearing to finalize recommendations to the Secretary of HHS.
Individuals and representatives of organizations interested in submitting written testimony are invited to respond to the following questions:
In general,
1. Would these recommendations as a whole improve the predictability of the adoption of administrative standards and operating rules?
2. What additional recommendations are critical to achieve predictability?
And specifically,
3. What is the value proposition of each recommendation and what improvements to the current state do you believe will arise from each recommendation/group of similar recommendations?
4. Are there potential unintended consequences? What are those and how can they be mitigated with modifications to the recommendations?
The questions outlined above can be used to guide written submissions to the Subcommittee. Written submissions should be sent electronically to
The times and topics for this meeting are subject to change. Please refer to the posted agenda at
Should you require reasonable accommodation, please contact the CDC Office of Equal Employment Opportunity on (770) 488-3210 as soon as possible.
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
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended notice is hereby given of a meeting of the Special Emphasis Panel.
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 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 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
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 materials, 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 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.
Federal Emergency Management Agency, DHS.
Notice.
FEMA gives notice that the statewide per capita impact indicator under the Public Assistance program for disasters declared on or after October 1, 2018, will be increased.
This adjustment applies to major disasters declared on or after October 1, 2018.
Jonathan Hoyes, Recovery Directorate, Federal Emergency Management Agency, 500 C Street SW, Washington, DC 20472, (202) 646-3834.
44 CFR 206.48 provides that FEMA will adjust the statewide per capita impact indicator under the Public Assistance program to reflect changes in the Consumer Price Index for All Urban Consumers published by the Department of Labor.
FEMA gives notice that the statewide per capita impact indicator will be increased to $1.50 for all disasters declared on or after October 1, 2018.
FEMA bases the adjustment on an increase in the Consumer Price Index for All Urban Consumers of 2.7 percent for the 12-month period that ended in August 2018. The Bureau of Labor Statistics of the U.S. Department of Labor released the information on September 13, 2018.
Federal Emergency Management Agency, DHS.
Notice.
FEMA gives notice that the countywide per capita impact indicator under the Public Assistance program for disasters declared on or after October 1, 2018, will be increased.
This adjustment applies to major disasters declared on or after October 1, 2018.
Jonathan Hoyes, Recovery Directorate, Federal Emergency Management Agency, 500 C Street SW, Washington, DC 20472, (202) 646-3834.
In assessing damages for area designations under 44 CFR 206.40(b), FEMA uses a countywide per capita indicator to evaluate the impact of the disaster at the county level. FEMA will adjust the countywide per capita impact indicator under the Public Assistance program to reflect annual changes in the Consumer Price Index for All Urban Consumers published by the Department of Labor.
FEMA gives notice of an increase in the countywide per capita impact indicator to $3.78 for all disasters declared on or after October 1, 2018.
FEMA bases the adjustment on an increase in the Consumer Price Index for All Urban Consumers of 2.7 percent for the 12-month period that ended in August 2018. The Bureau of Labor Statistics of the U.S. Department of Labor released the information on September 13, 2018.
Federal Emergency Management Agency, DHS.
Notice.
FEMA gives notice that the minimum Project Worksheet Amount under the Public Assistance program for disasters and emergencies declared on or after October 1, 2018, will be increased.
This adjustment applies to major disasters and emergencies declared on or after October 1, 2018.
Jonathan Hoyes, Recovery Directorate, Federal Emergency Management Agency, 500 C Street SW, Washington, DC 20472, (202) 646-3834.
The Robert T. Stafford Disaster Relief and Emergency Assistance Act 42 U.S.C. 5121-5207 and 44 CFR 206.202(d)(2) provide that FEMA will annually adjust the minimum Project Worksheet amount under the Public Assistance program to reflect changes in the Consumer Price Index for All Urban Consumers published by the Department of Labor.
FEMA gives notice of an increase to $3,200 for the minimum amount that will be approved for any Project Worksheet under the Public Assistance program for all major disasters and emergencies declared on or after October 1, 2018.
FEMA bases the adjustment on an increase in the Consumer Price Index for All Urban Consumers of 2.7 percent for the 12-month period that ended in August 2018. This is based on information released by the Bureau of Labor Statistics at the U.S. Department of Labor on September 13, 2018.
Federal Emergency Management Agency, DHS.
Committee management; Notice of open Federal Advisory Committee meeting.
The Federal Emergency Management Agency (FEMA) National Advisory Council (NAC) will meet in person on November 6-8, 2018, in Washington, DC. The meeting will be open to the public.
The NAC will meet Tuesday, November 6, 2018, from 8:00 a.m. to 5:00 p.m., Wednesday, November 7, 2018, from 8:30 a.m. to 5:00 p.m., and Thursday, November 8, 2018, from 8:30 a.m. to 1:00 p.m. Eastern Time (ET). Please note that the meeting may close early if the NAC has completed its business.
The meeting will be held at The National Association of Counties, located at 660 North Capitol Street NW, Washington, DC 20001. It is recommended that attendees register with FEMA by October 26, 2018, by providing their name, telephone number, email address, title, and organization to the person listed in the
For information on facilities or services for people with disabilities and others with access and functional needs (including people who use mobility aids, require medication or portable medical equipment, use service animals, need information in alternate formats, or rely on personal assistance services), or to request assistance at the meeting, contact the person listed in the
To facilitate public participation, members of the public are invited to provide written comments on the issues to be considered by the NAC. The “Agenda” section below outlines these issues. The full agenda and any related documents for this meeting will be posted by Friday, November 2, 2018, on the NAC website at
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A public comment period will be held on Wednesday, November 7, 2018, from 1:00 p.m. to 1:15 p.m. ET. All speakers must limit their comments to 5 minutes. Comments should be addressed to the NAC. Any comments not related to the agenda topics will not be considered by the NAC. To register to make remarks during the public comment period, contact the individual listed in the
Deana Platt, Designated Federal Officer, Office of the National Advisory Council, Federal Emergency Management Agency, 500 C Street SW, Washington, DC 20472-3184, telephone (202) 646-2700, Fax (540) 504-2331, and email
Notice of this meeting is given under the Federal Advisory Committee Act, 5 U.S.C. Appendix.
The NAC advises the FEMA Administrator on all aspects of emergency management. The NAC incorporates input from state, local, tribal and territorial governments, and the private sector in the development and revision of FEMA plans and strategies. The NAC includes a cross-section of officials, emergency managers, and emergency response providers from state, local, tribal, and territorial governments, the private sector, and nongovernmental organizations.
On Wednesday, November 7, 2018, the Integrated Public Alert and Warning System Subcommittee will present its recommendations to the full NAC for consideration and, based on group discussion, the NAC will vote to make recommendations as appropriate to the FEMA Administrator. Following this, the three permanent and one ad-hoc NAC subcommittees (Federal Insurance and Mitigation Subcommittee, Preparedness and Protection Subcommittee, Response and Recovery Subcommittee, and Tribal Subcommittee) will discuss and deliberate on their potential recommendations and again, based on group discussion, the NAC will vote to make recommendations as appropriate to the FEMA Administrator. Potential recommendation topics include (1) leveraging communities to build a culture of preparedness, (2) engaging the whole community in planning and response, and (3) closing the insurance gap.
On Thursday, November 8, 2018, the NAC will review potential topics for research before the next in-person meeting, discuss recent disasters, review agreed upon recommendations, and confirm charges for the subcommittees.
The full agenda and any related documents for this meeting will be posted by Friday, November 2, 2018, on the NAC website at
Federal Emergency Management Agency, DHS.
Notice.
FEMA gives notice of the maximum amount for assistance under the Individuals and Households Program for emergencies and major disasters declared on or after October 1, 2018.
This adjustment applies to emergencies and major disasters declared on or after October 1, 2018.
Christopher B. Smith, Recovery Directorate, Federal Emergency Management Agency, 500 C Street SW, Washington, DC 20472, (202) 212-1000.
Section 408 of the Robert T. Stafford Disaster Relief and Emergency Assistance Act (the Stafford Act), 42 U.S.C. 5174, prescribes that FEMA must annually adjust the maximum amount for assistance provided under the Individuals and Households Program (IHP). FEMA gives notice that the maximum amount of IHP financial assistance provided to an individual or household under section 408 of the Stafford Act with respect to any single emergency or major disaster is $34,900. The increase in award amount as stated above is for any single emergency or major disaster declared on or after October 1, 2018. In addition, in accordance with 44 CFR 61.17(c), this adjustment includes the maximum amount of available coverage under any Group Flood Insurance Policy (GFIP) issued.
FEMA bases the adjustment on an increase in the Consumer Price Index for All Urban Consumers of 2.7 percent for the 12-month period, which ended in August 2018. The Bureau of Labor Statistics of the U.S. Department of Labor released the information on September 13, 2018.
Federal Emergency Management Agency, DHS.
Notice.
FEMA gives notice of an adjustment to the threshold for Small Project subgrants made to state, tribal, and local governments and private nonprofit facilities for disasters declared on or after October 1, 2018.
This adjustment applies to major disasters and emergencies declared on or after October 1, 2018.
Jonathan Hoyes, Recovery Directorate, Federal Emergency Management Agency, 500 C Street SW, Washington, DC 20472, (202) 646-3834.
The Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121-5207, as amended by the Sandy Recovery Improvement Act, Public Law 113-2, provides that FEMA will annually adjust the threshold for assistance provided under section 422, Simplified Procedures, relating to the Public Assistance program, to reflect changes in the Consumer Price Index for All Urban Consumers published by the Department of Labor.
FEMA gives notice that $128,900 is the threshold for any Small Project subgrant made to state, tribal, and local
FEMA bases the adjustment on an increase in the Consumer Price Index for All Urban Consumers of 2.7 percent for the 12-month period that ended in August 2018. This is based on information released by the Bureau of Labor Statistics at the U.S. Department of Labor on September 13, 2018.
Federal Emergency Management Agency, DHS.
Notice.
This is a notice of the Presidential declaration of an emergency for the State of Florida (FEMA-3405-EM), dated October 9, 2018, and related determinations.
The declaration was issued October 9, 2018.
Dean Webster, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW, Washington, DC 20472, (202) 646-2833.
Notice is hereby given that, in a letter dated October 9, 2018, the President issued an emergency declaration under the authority of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121-5207 (the Stafford Act), as follows:
I have determined that the emergency conditions in certain areas of the State of Florida resulting from Hurricane Michael beginning on October 7, 2018, and continuing, are of sufficient severity and magnitude to warrant an emergency declaration under the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121
You are authorized to provide appropriate assistance for required emergency measures, authorized under Title V of the Stafford Act, to save lives and to protect property and public health and safety, and to lessen or avert the threat of a catastrophe in the designated areas. Specifically, you are authorized to provide assistance for debris removal and emergency protective measures (Categories A and B), including direct Federal assistance, under the Public Assistance program in selected areas and emergency protective measures (Category B), limited to direct Federal assistance, under the Public Assistance program in selected areas.
Consistent with the requirement that Federal assistance be supplemental, any Federal funds provided under the Stafford Act for Public Assistance will be limited to 75 percent of the total eligible costs. In order to provide Federal assistance, you are hereby authorized to allocate from funds available for these purposes such amounts as you find necessary for Federal emergency assistance and administrative expenses.
Further, you are authorized to make changes to this declaration for the approved assistance to the extent allowable under the Stafford Act.
The Federal Emergency Management Agency (FEMA) hereby gives notice that pursuant to the authority vested in the Administrator, Department of Homeland Security, under Executive Order 12148, as amended, Thomas J. McCool, of FEMA is appointed to act as the Federal Coordinating Officer for this declared emergency.
The following areas of the State of Florida have been designated as adversely affected by this declared emergency:
Debris removal and emergency protective measures (Categories A and B), including direct federal assistance, under the Public Assistance program for Bay, Calhoun, Franklin, Gadsden, Gulf, Hamilton, Jackson, Jefferson, Leon, Liberty, Madison, Suwannee, Taylor, and Wakulla Counties.
Emergency protective measures (Category B), limited to direct federal assistance, under the Public Assistance program for Alachua, Baker, Bradford, Citrus, Columbia, Dixie, Escambia, Gilchrist, Hernando, Hillsborough, Holmes, Lafayette, Levy, Manatee, Okaloosa, Pasco, Pinellas, Santa Rosa, Union, Walton, and Washington Counties.
Office of the Assistant Secretary for Policy Development and Research, HUD.
Notice.
This document designates “Difficult Development Areas” (DDAs) and “Qualified Census Tracts” (QCTs) for purposes of the Low-Income Housing Tax Credit (LIHTC) under Internal Revenue Code (IRC) Section 42, as enacted by the Tax Reform Act of 1986. The United States Department of Housing and Urban Development (HUD) makes new DDA and QCT designations annually.
For questions on how areas are designated and on geographic definitions, contact Michael K. Hollar, Senior Economist, Economic Development and Public Finance Division, Office of Policy Development and Research, Department of Housing and Urban Development, 451 Seventh Street SW, Room 8216, Washington, DC 20410-6000; telephone number 202-402-5878, or send an email to
Under 26 U.S.C. 42(d)(5)(B)(iii), for purposes of the LIHTC, the Secretary of HUD must designate DDAs, which are areas with high construction, land, and utility costs relative to area median gross income. This notice designates DDAs for each of the 50 states, the District of Columbia, Puerto Rico, American Samoa, Guam, the Northern Mariana Islands, and the U.S. Virgin Islands. The designations of DDAs in this notice are based on modified Fiscal Year (FY) 2018 Small Area Fair Market Rents (Small Area FMRs), FY2018 nonmetropolitan county FMRs, FY2018 income limits, and 2010 Census population counts, as explained below.
Similarly, under 26 U.S.C. 42(d)(5)(B)(ii), the Secretary of HUD must designate QCTs, which are areas where either 50 percent or more of the households have an income less than 60 percent of the area median gross income for such year or have a poverty rate of at least 25 percent. This notice designates QCTs based on new income and poverty data released in the American Community Survey (ACS). Specifically, HUD relies on the most recent three sets of ACS data to ensure that anomalous estimates, due to sampling, do not affect the QCT status of tracts.
Data from the 2010 Census on total population of metropolitan areas, metropolitan Zip Code Tabulation Areas (ZCTAs), and nonmetropolitan areas are used in the designation of DDAs. The Office of Management and Budget (OMB) first published new metropolitan area definitions incorporating 2010 Census data in OMB Bulletin No. 15-01 on July 15, 2015. FY2018 FMRs and FY2018 income limits used to designate DDAs are based on these metropolitan statistical area (MSA) definitions, with modifications to account for substantial differences in rental housing markets (and, in some cases, median income levels) within MSAs. Small Area FMRs are calculated for the ZCTAs, or portions of ZCTAs within the metropolitan areas defined by OMB Bulletin No. 15-01.
Data from the 2010 Census on total population of census tracts, metropolitan areas, and the nonmetropolitan parts of states are used in the designation of QCTs. The FY2018 income limits used to designate QCTs are based on these MSA definitions with modifications to account for substantial differences in rental housing markets (and in some cases median income levels) within MSAs. This QCT designation uses the OMB metropolitan area definitions published in OMB Bulletin No. 15-01 on July 15, 2015, without modification for purposes of evaluating how many census tracts can be designated under the population cap, but uses the HUD-modified definitions and their associated area median incomes for determining QCT eligibility.
Because the 2010 Decennial Census did not include questions on respondent household income, HUD uses ACS data to designate QCTs. The ACS tabulates data collected over 5 years to provide estimates of socioeconomic variables for small areas containing fewer than 65,000 persons, such as census tracts. Due to sample-related anomalies in estimates from year to year, HUD utilizes three sets of ACS tabulations to ensure that anomalous estimates do not affect QCT status.
The U.S. Department of the Treasury (Treasury) and its Internal Revenue Service (IRS) are authorized to interpret and enforce the provisions of the LIHTC found at IRC Section 42. In order to assist in understanding HUD's mandated designation of DDAs and QCTs for use in administering IRC Section 42, a summary of the section is provided below. The following summary does not purport to bind Treasury or the IRS in any way, nor does it purport to bind HUD, since HUD has authority to interpret or administer the IRC only in instances where it receives explicit statutory delegation.
The LIHTC is a tax incentive intended to increase the availability of low-income rental housing. IRC Section 42 provides an income tax credit to certain owners of newly constructed or substantially rehabilitated low-income rental housing projects. The dollar amount of the LIHTC available for allocation by each state (credit ceiling) is limited by population. Each state is allowed a credit ceiling based on a statutory formula indicated at IRC Section 42(h)(3). States may carry forward unallocated credits derived from the credit ceiling for one year; however, to the extent such unallocated credits are not used by then, the credits go into a national pool to be redistributed to states as additional credit. State and local housing agencies allocate the state's credit ceiling among low-income housing buildings whose owners have applied for the credit. Besides IRC Section 42 credits derived from the credit ceiling, states may also provide IRC Section 42 credits to owners of buildings based on the percentage of certain building costs financed by tax-exempt bond proceeds. Credits provided under the tax-exempt bond “volume cap” do not reduce the credits available from the credit ceiling.
The credits allocated to a building are based on the cost of units placed in service as low-income units under particular minimum occupancy and maximum rent criteria. Prior to the enactment of the Consolidated Appropriations Act of 2018 (Act), under IRC Section 42(h), a building was required to meet one of two tests to be eligible for the LIHTC; either: (1) 20 percent of the units must be rent-restricted and occupied by tenants with incomes no higher than 50 percent of the Area Median Gross Income (AMGI), or (2) 40 percent of the units must be rent-restricted and occupied by tenants with incomes no higher than 60 percent of AMGI. A unit is “rent-restricted” if the gross rent, including an allowance for tenant-paid utilities, does not exceed 30 percent of the imputed income limitation (
The Act added a third test, the average income test. See § 42(g)(1), as amended by section 103(a)(1), Division T, of the Act. A building meets the minimum requirements of the average income test if 40 percent or more (25 percent or more in the case of a project located in a high cost housing area as described in IRS Section 142(d)(6)) of the residential units in such project are both rent-restricted and occupied by individuals whose income does not exceed the imputed income limitation designated by the taxpayer with respect to the respective unit. The taxpayer designates the imputed income limitation for each unit. The designated imputed income limitation of any unit is determined in 10-percentage-point increments, and may be designated as
The LIHTC reduces income tax liability dollar-for-dollar. It is taken annually for a term of 10 years and is intended to yield a present value of either: (1) 70 percent of the “qualified basis” for new construction or substantial rehabilitation expenditures that are not federally subsidized (as defined in IRC Section 42(i)(2)), or (2) 30 percent of the qualified basis for the cost of acquiring certain existing buildings or projects that are federally subsidized. The tax credit rates are determined monthly under procedures specified in IRC Section 42 and cannot be less than 9 percent for new buildings that are not federally subsidized. Individuals can use the credits up to a deduction equivalent of $25,000 (the actual maximum amount of credit that an individual can claim depends on the individual's marginal tax rate). For buildings placed in service after December 31, 2007, individuals can use the credits against the alternative minimum tax. Corporations, other than S or personal service corporations, can use the credits against ordinary income tax, and, for buildings placed in service after December 31, 2007, against the alternative minimum tax. These corporations also can deduct losses from the project.
The qualified basis represents the product of the building's “applicable fraction” and its “eligible basis.” The applicable fraction is based on the number of low-income units in the building as a percentage of the total number of units, or based on the floor space of low-income units as a percentage of the total floor space of residential units in the building. The eligible basis is the adjusted basis attributable to acquisition, rehabilitation, or new construction costs (depending on the type of LIHTC involved). These costs include amounts chargeable to a capital account that are incurred prior to the end of the first taxable year in which the qualified low-income building is placed in service or, at the election of the taxpayer, the end of the succeeding taxable year. In the case of buildings located in designated DDAs or designated QCTs, or buildings designated by the state agency, eligible basis can be increased up to 130 percent from what it would otherwise be. This means that the available credits also can be increased by up to 30 percent. For example, if a 70 percent credit is available, it effectively could be increased to as much as 91 percent (70 percent × 130 percent).
As stated above, IRC Section 42 defines a DDA as an area designated by the Secretary of HUD that has high construction, land, and utility costs relative to the AMGI. All designated DDAs in metropolitan areas (taken together) may not contain more than 20 percent of the aggregate population of all metropolitan areas, and all designated areas not in metropolitan areas may not contain more than 20 percent of the aggregate population of all nonmetropolitan areas.
Similarly, IRC Section 42 defines a QCT as an area designated by the Secretary of HUD where, for the most recent year for which census data are available on household income in such tract, either 50 percent or more of the households in the tract have an income which is less than 60 percent of the area median gross income or the tract's poverty rate is at least 25 percent. All designated QCTs in a single metropolitan area or nonmetropolitan area (taken together) may not contain more than 20 percent of the population of that metropolitan or nonmetropolitan area. Thus, unlike the restriction on DDA designations, QCTs are restricted by the total population of each individual area as opposed to the aggregate population across all metropolitan areas and nonmetropolitan areas.
IRC Section 42(d)(5)(B)(v) allows states to award an increase in basis up to 30 percent to buildings located outside of federally designated DDAs and QCTs if the increase is necessary to make the building financially feasible. This state discretion applies only to buildings allocated credits under the state housing credit ceiling and is not permitted for buildings receiving credits in connection with tax-exempt bonds. Rules for such designations shall be set forth in the LIHTC-allocating agencies' qualified allocation plans (QAPs).
In developing the 2019 list of DDAs, as required by 26 U.S.C. 42(d)(5)(B)(iii), HUD compared housing costs with incomes. HUD used 2010 Census population for ZCTAs, and nonmetropolitan areas, and the MSA definitions, as published in OMB Bulletin 15-01 on July 15, 2015, with modifications, as described below. In keeping with past practice of basing the coming year's DDA designations on data from the preceding year, the basis for these comparisons is the FY2018 HUD income limits for very low-income households (very low-income limits, or VLILs), which are based on 50 percent of AMGI, and modified FMRs based on the FY2018 FMRs used for the Housing Choice Voucher (HCV) program. For metropolitan DDAs, HUD used Small Area FMRs based on three annual releases of ACS data, to compensate for statistical anomalies which affect estimates for some ZCTAs. For non-metropolitan DDAs, HUD used the FY2018 FMRs published on October 2, 2017 (83 FR 7205) as updated through February 20, 2018 (83 FR 7205).
In formulating the FY2018 FMRs and VLILs, HUD modified the current OMB definitions of MSAs to account for differences in rents among areas within each current MSA that were in different FMR areas under definitions used in prior years. HUD formed these “HUD Metro FMR Areas” (HMFAs) in cases where one or more of the parts of newly defined MSAs were previously in separate FMR areas. All counties added to metropolitan areas are treated as HMFAs with rents and incomes based on their own county data, where available. HUD no longer requires recent-mover rents to differ by five percent or more in order to form a new HMFA. All HMFAs are contained entirely within MSAs. All nonmetropolitan counties are outside of MSAs and are not broken up by HUD for purposes of setting FMRs and VLILs. (Complete details on HUD's process for determining FY2018 FMR areas and FMRs are available at
HUD's unit of analysis for designating metropolitan DDAs consists of ZCTAs, whose Small Area FMRs are compared to metropolitan VLILs. For purposes of computing VLILs in metropolitan areas, HUD considers entire MSAs in cases where these were not broken up into HMFAs for purposes of computing VLILs; and HMFAs within the MSAs that were broken up for such purposes. Hereafter in this notice, the unit of analysis for designating metropolitan DDAs will be called the ZCTA, and the unit of analysis for nonmetropolitan
1.
The modified FY2018 two-bedroom Small Area FMRs for ZCTAs differ from the FY2018 Small Area FMRs in four ways. First, HUD did not limit the Small Area FMR to 150 percent of its metropolitan area FMR. Second, HUD did not limit annual decreases in Small Area FMRs to ten percent, which was first applied in the FY2018 FMR calculations. Third, HUD adjusted the Small Area FMRs in New York City using the New York City Housing and Vacancy Survey, which is conducted by the U.S. Census Bureau, to adjust for the effect of local rent control and stabilization regulations. No other jurisdictions have provided HUD with data that could be used to adjust Small Area FMRs for rent control or stabilization regulations.
The numerator of the ratio, representing the development cost of housing, was the area's FY2018 FMR, or Small Area FMR in metropolitan areas. In general, the FMR is based on the 40th-percentile gross rent paid by recent movers to live in a two-bedroom rental unit.
The denominator of the ratio, representing the maximum income of eligible tenants, was the monthly LIHTC income-based rent limit, which was calculated as 1/12 of 30 percent of 120 percent of the area's VLIL (where the VLIL was rounded to the nearest $50 and not allowed to exceed 80 percent of the AMGI in areas where the VLIL is adjusted upward from its 50 percent-of-AMGI base).
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In identifying DDAs, HUD applied caps, or limitations, as noted above. The cumulative population of metropolitan DDAs cannot exceed 20 percent of the cumulative population of all metropolitan areas, and the cumulative population of nonmetropolitan DDAs cannot exceed 20 percent of the cumulative population of all nonmetropolitan areas.
In applying these caps, HUD established procedures to deal with how to treat small overruns of the caps. The remainder of this section explains those procedures. In general, HUD stops selecting areas when it is impossible to choose another area without exceeding the applicable cap. The only exceptions to this policy are when the next eligible excluded area contains either a large absolute population or a large percentage of the total population, or the next excluded area's ranking ratio, as described above, was identical (to four decimal places) to the last area selected, and its inclusion resulted in only a minor overrun of the cap. Thus, for both the designated metropolitan and nonmetropolitan DDAs, there may be minimal overruns of the cap. HUD believes the designation of additional areas in the above examples of minimal overruns is consistent with the intent of the IRC. As long as the apparent excess is small due to measurement errors, some latitude is justifiable, because it is impossible to determine whether the 20 percent cap has been exceeded. Despite the care and effort involved in a Decennial Census, the Census Bureau and all users of the data recognize that the population counts for a given area and for the entire country are not precise. Therefore, the extent of the measurement error is unknown. There can be errors in both the numerator and denominator of the ratio of populations used in applying a 20 percent cap. In circumstances where a strict application of a 20 percent cap results in an anomalous situation, recognition of the unavoidable imprecision in the census data justifies accepting small variances above the 20 percent limit.
In developing the list of QCTs, HUD used 2010 Census 100-percent count data on total population, total households, and population in households; the median household income and poverty rate as estimated in the 2010-2014, 2011-2015 and 2012-2016, ACS tabulations; the FY2018 Very Low-Income Limits (VLILs) computed at the HUD Metropolitan FMR Area (HMFA) level to determine tract eligibility; and the MSA definitions published in OMB Bulletin No. 15-01 on July 15, 2015, for determining how many eligible tracts can be designated under the statutory 20 percent population cap.
HUD uses the HMFA-level AMGIs to determine QCT eligibility because the statute, specifically IRC Section 42(d)(5)(B)(iv)(II), refers to the same section of the IRC that defines income for purposes of tenant eligibility and unit maximum rent, specifically IRC Section 42(g)(4). By rule, the IRS sets these income limits according to HUD's VLILs, which, starting in FY2006 and thereafter, are established at the HMFA level. HUD uses the entire MSA to determine how many eligible tracts can be designated under the 20 percent population cap as required by the statute (IRC Section 42(d)(5)(B)(ii)(III)), which states that MSAs should be treated as singular areas.
The QCTs were determined as follows:
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a. The statistically reliable income and poverty criteria are each averaged over the three ACS tabulations (2010-2014, 2011-2015 and 2012-2016). Statistically reliable values that did not exceed the income and poverty rate thresholds were included in the average.
b. Eligible tracts are placed in one of two groups based on the averaged values of the income and poverty criteria. The first group includes tracts that satisfy both the income and poverty criteria for QCTs for at least two of the three evaluation years; a different pair of years may be used to meet each criterion. The second group includes tracts that satisfy either the income criterion in at least two of the three years, or the poverty criterion in at least two of three years, but not both. A tract must qualify by at least one of the criteria in at least two of the three evaluation years to be eligible.
c. Tracts in the first group are ranked from highest to lowest by the average of the ratios of the tract average-household-size-adjusted income limit to the median household income. Then, tracts in the first group are ranked from highest to lowest by the average of the poverty rates. The two ranks are averaged to yield a combined rank. The tracts are then sorted on the combined rank, with the census tract with the highest combined rank being placed at the top of the sorted list. In the event of a tie, more populous tracts are ranked above less populous ones.
d. Tracts in the second group are ranked from highest to lowest by the average of the ratios of the tract average-household-size-adjusted income limit to the median household income. Then, tracts in the second group are ranked from highest to lowest by the average of the poverty rates. The two ranks are then averaged to yield a combined rank. The tracts are then sorted on the combined rank, with the census tract with the highest combined rank being placed at the top of the sorted list. In the event of a tie, more populous tracts are ranked above less populous ones.
e. The ranked first group is stacked on top of the ranked second group to yield a single, concatenated, ranked list of eligible census tracts.
f. Working down the single, concatenated, ranked list of eligible tracts, census tracts are identified as designated until the designation of an additional tract would cause the 20 percent limit to be exceeded. If a census tract is not designated because doing so would raise the percentage above 20 percent, subsequent eligible census tracts are then considered to determine if one or more eligible census tract(s) with smaller population(s) could be designated without exceeding the 20 percent limit.
As stated in OMB Bulletin 15-01, defining metropolitan areas:
“OMB establishes and maintains the delineations of Metropolitan Statistical Areas, . . . solely for statistical purposes. . . . OMB does not take into account or attempt to anticipate any non-statistical uses that may be made of the delineations, [.] In cases where . . . an agency elects to use the Metropolitan . . . Area definitions in nonstatistical programs, it is the sponsoring agency's responsibility to ensure that the delineations are appropriate for such use. An agency using the statistical delineations in a nonstatistical program may modify the delineations, but only for the purposes of that program. In such cases, any modifications should be clearly identified as delineations from the OMB statistical area delineations in order to avoid confusion with OMB's official definitions of Metropolitan . . . Statistical Areas.”
Following OMB guidance, the estimation procedure for the FMRs and income limits incorporates the current OMB definitions of metropolitan areas based on the CBSA standards, as implemented with 2010 Census data, but makes adjustments to the definitions, in order to separate subparts of these areas in cases where counties were added to an existing or newly defined metropolitan area. In CBSAs where subareas are established, it is HUD's view that the geographic extent of the housing markets are not the same as the geographic extent of the CBSAs.
In the New England states (Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island, and Vermont), HMFAs are defined according to county subdivisions or minor civil divisions (MCDs), rather than county boundaries. However, since no part of an HMFA is outside an OMB-defined, county-based MSA, all New England nonmetropolitan counties are kept intact for purposes of designating Nonmetropolitan DDAs.
DDAs are designated annually as updated income and FMR data are made public. QCTs are designated annually as new income and poverty rate data are released.
The 2019 lists of QCTs and DDAs are effective:
(1) for allocations of credit after December 31, 2018; or
(2) for purposes of IRC Section 42(h)(4), if the bonds are issued and the building is placed in service after December 31, 2018.
If an area is not on a subsequent list of QCTs or DDAs, the 2019 lists are effective for the area if:
(1) the allocation of credit to an applicant is made no later than the end of the 730-day period after the applicant submits a complete application to the LIHTC-allocating agency, and the submission is made before the effective date of the subsequent lists; or
(2) for purposes of IRC Section 42(h)(4), if:
(a) The bonds are issued or the building is placed in service no later than the end of the 730-day period after the applicant submits a complete application to the bond-issuing agency, and
(b) the submission is made before the effective date of the subsequent lists, provided that both the issuance of the bonds and the placement in service of the building occur after the application is submitted.
An application is deemed to be submitted on the date it is filed if the application is determined to be complete by the credit-allocating or bond-issuing agency. A “complete application” means that no more than de minimis clarification of the application is required for the agency to make a decision about the allocation of tax credits or issuance of bonds requested in the application.
In the case of a “multiphase project,” the DDA or QCT status of the site of the project that applies for all phases of the project is that which applied when the project received its first allocation of LIHTC. For purposes of IRC Section 42(h)(4), the DDA or QCT status of the site of the project that applies for all phases of the project is that which applied when the first of the following occurred: (a) The building(s) in the first phase were placed in service, or (b) the bonds were issued.
For purposes of this notice, a “multiphase project” is defined as a set of buildings to be constructed or rehabilitated under the rules of the LIHTC and meeting the following criteria:
(1) The multiphase composition of the project (
(2) the aggregate amount of LIHTC applied for on behalf of, or that would eventually be allocated to, the buildings on the site exceeds the one-year limitation on credits per applicant, as defined in the Qualified Allocation Plan (QAP) of the LIHTC-allocating agency, or the annual per-capita credit authority of the LIHTC allocating agency, and is the reason the applicant must request multiple allocations over 2 or more years; and
(3) all applications for LIHTC for buildings on the site are made in immediately consecutive years.
Members of the public are hereby reminded that the Secretary of Housing and Urban Development, or the Secretary's designee, has legal authority to designate DDAs and QCTs, by publishing lists of geographic entities as defined by, in the case of DDAs, the Census Bureau, the several states and the governments of the insular areas of the United States and, in the case of QCTs, by the Census Bureau; and to establish the effective dates of such lists. The Secretary of the Treasury, through the IRS thereof, has sole legal authority to interpret, and to determine and enforce compliance with the IRC and associated regulations, including
For the convenience of readers of this notice, interpretive examples are provided below to illustrate the consequences of the effective date in areas that gain or lose QCT or DDA status. The examples covering DDAs are equally applicable to QCT designations.
(Case A) Project A is located in a 2019 DDA that is NOT a designated DDA in 2020 or 2021. A complete application for tax credits for Project A is filed with the allocating agency on November 15, 2019. Credits are allocated to Project A on October 30, 2021. Project A is eligible for the increase in basis accorded a project in a 2019 DDA because the application was filed BEFORE January 1, 2020 (the assumed effective date for the 2020 DDA lists), and because tax credits were allocated no later than the end of the 730-day period after the filing of the complete application for an allocation of tax credits.
(Case B) Project B is located in a 2019 DDA that is NOT a designated DDA in 2020 or 2021. A complete application for tax credits for Project B is filed with the allocating agency on December 1, 2019. Credits are allocated to Project B on March 30, 2022. Project B is NOT eligible for the increase in basis accorded a project in a 2019 DDA because, although the application for an allocation of tax credits was filed BEFORE January 1, 2020 (the assumed effective date of the 2020 DDA lists), the tax credits were allocated later than the end of the 730-day period after the filing of the complete application.
(Case C) Project C is located in a 2019 DDA that was not a DDA in 2018. Project C was placed in service on November 15, 2018. A complete application for tax-exempt bond financing for Project C is filed with the bond-issuing agency on January 15, 2019. The bonds that will support the permanent financing of Project C are issued on September 30, 2019. Project C is NOT eligible for the increase in basis otherwise accorded a project in a 2019 DDA, because the project was placed in service BEFORE January 1, 2019.
(Case D) Project D is located in an area that is a DDA in 2019 but is NOT a DDA in 2020 or 2021. A complete application for tax-exempt bond financing for Project D is filed with the bond-issuing agency on October 30, 2019. Bonds are issued for Project D on April 30, 2021, but Project D is not placed in service until January 30, 2022. Project D is eligible for the increase in basis available to projects located in 2019 DDAs because: (1) one of the two events necessary for triggering the effective date for buildings described in Section 42(h)(4)(B) of the IRC (the two events being bonds issued and buildings placed in service) took place on April 30, 2021, within the 730-day period after a complete application for tax-exempt bond financing was filed, (2) the application was filed during a time when the location of Project D was in a DDA, and (3) both the issuance of the bonds and placement in service of Project D occurred after the application was submitted.
(Case E) Project E is a multiphase project located in a 2019 DDA that is NOT a designated DDA or QCT in 2020. The first phase of Project E received an allocation of credits in 2019, pursuant to an application filed March 15, 2019,
(Case F) Project F is a multiphase project located in a 2019 DDA that is NOT a designated DDA in 2020 or 2021. The first phase of Project F received an allocation of credits in 2019, pursuant to an application filed March 15, 2019, which does not describe the multiphase composition of the project. An application for tax credits for the second phase of Project F is filed with the allocating agency by the same entity on March 15, 2021. Credits are allocated to the second phase of Project F on October 30, 2021. The aggregate amount of credits allocated to the two phases of Project F exceeds the amount of credits that may be allocated to an applicant in one year under the allocating agency's QAP. The second phase of Project F is, therefore, NOT eligible for the increase in basis accorded a project in a 2019 DDA, since it does not meet all of the conditions for a multiphase project, as defined in this notice. The original application for credits for the first phase did not describe the multiphase composition of the project. Also, the application for credits for the second phase of Project F was not made in the year immediately following the first phase application year.
This notice involves the establishment of fiscal requirements or procedures that are related to rate and cost determinations and do not constitute a development decision affecting the physical condition of specific project areas or building sites. Accordingly, under 40 CFR 1508.4 of the regulations of the Council on Environmental Quality and 24 CFR 50.19(c)(6) of HUD's regulations, this notice is categorically excluded from environmental review under the National Environmental Policy Act of 1969 (42 U.S.C. 4321).
Executive Order 13132 (entitled “Federalism”) prohibits an agency from publishing any policy document that has federalism implications if the document either imposes substantial direct compliance costs on state and local governments and is not required by statute, or the document preempts state law, unless the agency meets the consultation and funding requirements of section 6 of the executive order. This notice merely designates DDAs and QCTs as required under IRC Section 42, as amended, for the use by political subdivisions of the states in allocating the LIHTC. This notice also details the technical methods used in making such designations. As a result, this notice is not subject to review under the order.
Office of the Assistant Secretary for Housing—Federal Housing Commissioner, HUD.
Notice.
HUD is seeking approval from the Office of Management and Budget (OMB) for the information collection described below. In accordance with the Paperwork Reduction Act, HUD is requesting comment from all interested parties on the proposed collection of information. The purpose of this notice is to allow for 60 days of public comment.
Interested persons are invited to submit comments regarding this proposal. Comments should refer to the proposal by name and/or OMB Control Number and should be sent to: Colette Pollard, Reports Management Officer, QDAM, Department of Housing and Urban Development, 451 7th Street SW, Room 4176, Washington, DC 20410-5000; telephone 202-402-3400 (this is not a toll-free number) or email at
Ivery Himes, Director, Office of Single Family Asset Management, Department of Housing and Urban Development, 451 7th Street SW, Washington, DC 20410, telephone 202-708-1672, extension 5628 (this is not a toll-free number) or email Colette Pollard at
Copies of available documents submitted to OMB may be obtained from Ms. Pollard.
This notice informs the public that HUD is seeking approval from OMB for the information collection described in Section A.
This notice is soliciting comments from members of the public and affected parties concerning the collection of information described in Section A on the following:
(1) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
HUD encourages interested parties to submit comment in response to these questions.
Section 3507 of the Paperwork Reduction Act of 1995, 44 U.S.C. Chapter 35.
Fish and Wildlife Service, Interior.
Notice of receipt of permit applications; request for comments.
We, the U.S. Fish and Wildlife Service, have received applications for permits to conduct activities intended to enhance the propagation or survival of endangered species under the Endangered Species Act of 1973, as amended. We invite the public and local, State, Tribal, and Federal agencies to comment on these applications. Before issuing any of the requested permits, we will take into consideration any information that we receive during the public comment period.
We must receive your written comments by November 21, 2018.
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Kathy Konishi, Recovery Permits Coordinator, Ecological Services, 303-236-4224 (phone);
We, the U.S. Fish and Wildlife Service, invite the public to comment on applications for a permit under section 10(a)(1)(A) of the Endangered Species Act, as amended (ESA; 16 U.S.C. 1531
With some exceptions, the ESA prohibits activities that constitute take of listed species unless a Federal permit is issued that allows such activity. The ESA's definition of “take” includes such activities as pursuing, harassing, trapping, capturing, or collecting in addition to hunting, shooting, harming, wounding, or killing.
A recovery permit issued by us under section 10(a)(1)(A) of the ESA authorizes the permittee to conduct activities with endangered or threatened species for scientific purposes that promote recovery or for enhancement of propagation or survival of the species. These activities often include such prohibited actions as capture and collection. Our regulations implementing section 10(a)(1)(A) for these permits are found in the Code of Federal Regulations at 50 CFR 17.22 for endangered wildlife species, 50 CFR 17.32 for threatened wildlife species, 50 CFR 17.62 for endangered plant species, and 50 CFR 17.72 for threatened plant species.
Proposed activities in the following permit requests are for the recovery and enhancement of propagation or survival of the species in the wild. The ESA requires that we invite public comment before issuing this permit. Accordingly, we invite local, State, Tribal, and Federal agencies and the public to submit written data, views, or arguments with respect to these applications. The comments and recommendations that will be most useful and likely to influence agency decisions are those supported by quantitative information or studies.
Written comments we receive become part of the administrative record associated with this
If we decide to issue permits to any of the applicants listed in this notice, we will publish a notice in the
We publish this notice under section 10(c) of the Endangered Species Act of 1973, as amended (16 U.S.C. 1531
Bureau of Indian Affairs, Interior.
Notice of information collection; request for comment.
In accordance with the Paperwork Reduction Act of 1995, we, the Bureau of Indian Education (BIE) are proposing to renew an information collection.
Interested persons are invited to submit comments on or before December 21, 2018.
Send your comments on this information collection request (ICR) by mail to Ms. Juanita Mendoza, U.S. Department of the Interior, Bureau of Indian Education, 1849 C Street NW, Washington, DC 20240; fax: (202) 208-3312; email:
To request additional information about this ICR, contact Ms. Juanita Mendoza, (202) 208-6123.
In accordance with the Paperwork Reduction Act of 1995, we provide the general public and other Federal agencies with an opportunity to comment on new, proposed, revised, and continuing collections of information. This helps us assess the impact of our information collection requirements and minimize the public's reporting burden. It also helps the public understand our information collection requirements and provide the requested data in the desired format.
We are soliciting comments on the proposed ICR that is described below. We are especially interested in public comment addressing the following issues: (1) Is the collection necessary to the proper functions of the BIE; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the BIE enhance the quality, utility, and clarity of the information to be collected; and (5) how might the BIE minimize the burden of this collection on the respondents, including through the use of information technology.
Comments that you submit in response to this notice are a matter of public record. We will include or summarize each comment in our request to OMB to approve this ICR. Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
An agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.
The authority for this action is the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Office of the Secretary, Office of Financial Management, Interior.
Notice of information collection; request for comment.
In accordance with the Paperwork Reduction Act of 1995, we, the Office of Financial Management are proposing to renew an information collection.
Interested persons are invited to submit comments on or before November 21, 2018.
Send written comments on this information collection request (ICR) to the Office of Management and Budget's Desk Officer for the Department of the Interior by email at
To request additional information about this ICR, contact Paul Batlan by email at
In accordance with the Paperwork Reduction Act of 1995, we provide the general public and other Federal agencies with an opportunity to comment on new, proposed, revised, and continuing collections of information. This helps us assess the impact of our information collection requirements and minimize the public's reporting burden. It also helps the public understand our information collection requirements and provide the requested data in the desired format.
A
We are again soliciting comments on the proposed ICR that is described below. We are especially interested in public comment addressing the following issues: (1) Is the collection necessary to the proper functions of the Office of Financial Management; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Office of Financial Management enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Office of Financial Management minimize the burden of this collection on the respondents, including through the use of information technology.
Comments that you submit in response to this notice are a matter of public record. Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
The information collected is as follows:
An agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.
The authority for this action is the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Bureau of Land Management, Interior.
Notice.
In compliance with the National Environmental Policy Act of 1969, as amended (NEPA), and the Federal Land Policy and Management Act of 1976, as amended (FLPMA), the Bureau of Land Management (BLM) Mount Lewis Field Office, Battle Mountain, Nevada, has prepared a Draft Environmental Impact Statement (DEIS) and is announcing the beginning of the public comment period to solicit public comments on the DEIS. Barrick Cortez, Inc. (BCI) is proposing to expand its existing Cortez Hills Project mining operations, which would require a modification to the Plan of Operations to increase the plan boundary by 4,279 acres: From 58,093 acres to 62,372 acres.
To ensure comments will be considered, the BLM must receive written comments on the Draft EIS within 45 days following the date the Environmental Protection Agency publishes its Notice of Availability in the
You may submit comments related to the Project by any of the following methods:
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Documents pertinent to this proposal may be examined at the Mount Lewis Field Office.
Kevin Hurrell, Project Manager; telephone: 775-635-4000; address: 50 Bastian Road, Battle Mountain, Nevada 89820; or email:
Barrick Cortez, Inc. (BCI) is proposing to expand its existing Cortez Hills Project mining operations, which is located southeast of Battle Mountain in Eureka and Lander Counties, Nevada. There are 54,825 acres of public lands within the Plan of Operations boundary that are administered by the BLM Mount Lewis Field Office, and 3,268 acres of private lands controlled by BCI. BCI was previously authorized to disturb 16,700 acres within their Plan of Operations boundary.
The proposed mine expansion, named the Deep South Expansion Project (Proposed Project) would require a modification to the Plan of Operations to increase the plan boundary by 4,279 acres: From 58,093 acres to 62,372 acres. The proposed modification would result in approximately 3,798 acres of new disturbance inside the new proposed plan boundary, of which 2,768 acres are public lands.
BCI currently employs about 1,250 people from the northern Nevada towns of Elko, Battle Mountain, Winnemucca, Eureka, Carlin, and surrounding areas. If the Deep South Expansion Project is approved, the company expects to extend the mine life and employment opportunities for its workforce by another 12 years.
BCI's purpose for the Deep South Expansion Project is to continue to profitably recover gold and silver from reserves and resources on federal mining claims in the Project Area utilizing, to the extent practical, existing facilities at BCI's currently permitted operations within the Project Area. The project need is to meet the prevailing market demand for gold. The prevailing market demand is adjusted on a daily basis on commodity exchanges throughout the world. This adjustment results from buyers and sellers agreeing
Under the Gold Acres Pit Partial Backfill Alternative, the proposed expansion of the existing Gold Acres Pit would be completed prior to development of the proposed satellite pits (Alta, Bellwether, and Pasture), with the waste rock from the satellite pits (30 million tons) placed as backfill in the Gold Acres Pit to an approximate elevation of 5,440 feet amsl (Figures 2-18 and 2-19). This would result in a 72-acre reduction in the proposed new disturbance for the Gold Acres North Waste Rock Facility. The pit bottom elevations for the expanded Gold Acres Pit and proposed satellite pits would be the same as described for the Proposed Action. No dewatering would be required for the proposed expansion of open pit operations at the Gold Acres Complex as the proposed pit bottom elevations would be above the groundwater table. Therefore, proposed dewatering and water management operations would be the same as under the Proposed Action.
Under the No Action Alternative the proposed facilities and facility modifications, as well as the proposed operations modifications, that comprise the Deep South Expansion Project would not be developed or implemented. Under this alternative, the existing mining and processing operations in the Project Area and the current off site transport of refractory ore to the Goldstrike Mill for processing and backhaul of Arturo Mine oxide ore to the Pipeline Complex for processing would continue under the terms of current permits and approvals as authorized by the BLM and State of Nevada.
The DEIS describes and analyzes the Proposed Project's direct, indirect, and cumulative impacts on all affected resources. In addition to the Proposed Project, one additional alternative was analyzed, including the Gold Acres Pit Partial Backfill alternative, and the No Action Alternative.
On March 29, 2017, a Notice of Intent was published in the
The BLM has utilized and coordinated the NEPA scoping and comment process to help fulfill the public involvement requirements under the National Historic Preservation Act (NHPA) (54 U.S.C. 306108) as provided in 36 CFR 800.2(d)(3), and the agency continues to do so. The information about historical and cultural resources within the area potentially affected by the Proposed Project has assisted the BLM in identifying and evaluating impacts to such resources in the context of both NEPA and the NHPA.
The BLM has consulted and continues to consult with Indian tribes on a government-to-government basis in accordance with Executive Order 13175 and other policies. Tribal concerns, including impacts to Indian trust assets and potential impacts to cultural resources have been analyzed in the DEIS. Federal, State, and local agencies, along with tribes and other stakeholders that may be interested in or affected by the Proposed Project, are invited to participate in the comment process.
Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
40 CFR 1501.7.
National Park Service, Interior.
Notice.
The National Park Service, U.S. Department of the Interior, is seeking nominations for individuals to be considered for appointment to the Made in America Outdoor Recreation Advisory Committee (Committee). The Committee provides advice to the Secretary of the Interior (Secretary) on the public-private partnerships across all public lands, with the goal of expanding access to and improving infrastructure on public lands and waterways.
Nominations must be postmarked by November 21, 2018.
Nominations should be sent to Shirley Sears, Office of Policy, National Park Service, 1849 C Street NW, Mail Stop 2659, Washington, DC 20240.
Shirley Sears, Office of Policy, National Park Service, 1849 C Street NW, Mail Stop 2659, Washington, DC 20240, telephone number 202-354-3955, or email
The Committee has been established as a discretionary committee by authority of the Secretary under 54 U.S.C. 100906, and is regulated by the Federal Advisory Committee Act (FACA), as amended (5 U.S.C. Appendix 1-16).
The Committee's duties are strictly advisory and include, but are not limited to, providing recommendations on policies and programs that: Expand and improve visitor infrastructure developed through public-private partnerships; implement sustainable operations embracing fair, efficient, and convenient fee collection and strategic use of the collected fees; improve interpretation using technology; and create better tools and/or opportunities for Americans to discover their lands and waters. The Committee also provides recommendations for implementation of Secretary's Order 3347—Conservation Stewardship and Outdoor Recreation.
The Committee meets approximately two times per year. The Secretary appoints members and their alternates to the Committee to serve up to a 3-year term. The Committee will not exceed 18 discretionary and 2 ex officio members.
Nominations are currently being sought for consideration in appointing two discretionary members to the Committee from among, but not limited to, the entities listed below. The nominees must be senior-level representatives of their organizations.
Nominations should be typed and must include a resume providing an adequate description of the nominee's
Members of the Committee serve without compensation. However, while away from their homes or regular places of business, Committee and subcommittee members engaged in Committee or subcommittee business that the Designated Federal Officer (DFO) has approved may be allowed travel expenses, including per diem in lieu of subsistence, as authorized by 5 U.S.C. 5703, in the same manner as persons employed intermittently in Federal Government service.
54 U.S.C. 100906
National Park Service, Interior.
Request for nominations.
The National Park Service (NPS), U.S. Department of the Interior is requesting nominations for qualified persons to serve as members of the Committee.
Written nominations must be received by December 6, 2018.
Nominations should be sent to Daphne Yun, U.S. Department of the Interior, National Park Service, Gateway National Recreation Area, Office of the Superintendent, 210 New York Avenue, Staten Island, New York 10305, or email
Daphne Yun, U.S. Department of the Interior, National Park Service, Gateway National Recreation Area, Sandy Hook Unit, 26 Hudson Road, Highlands, New Jersey 07732, or email at
The Gateway National Recreation Area Fort Hancock 21st Century Advisory Committee was established by authority of the Secretary of the Interior under 54 U.S.C. 100906, and in accordance with the Federal Advisory Committee Act (5 U.S.C. Appendix 1-16). The purpose of the Committee is to advise the Secretary of the Interior, through the Director of the National Park Service, on the development of a reuse plan and on matters relating to future uses of certain buildings at the Fort Hancock Historic District, located within the Sandy Hook Unit of Gateway National Recreation Area in New Jersey.
The Committee consists of representatives from among, but not limited to, the following interest groups to represent a range of interests concerned with the management of Fort Hancock within the park and its impact on the local area: The natural resource community, the business community, the cultural resource community, the real estate community, the recreation community, the education community, the scientific community, and hospitality organizations. The Committee will also include representatives from the following municipalities: Borough of Highlands, Borough of Sea Bright, Borough of Rumson, Middletown Township, Monmouth County Freeholders, and Borough of Monmouth Beach.
We are currently seeking members to represent all categories.
Nominations should be typed and should include a resume providing an adequate description of the nominee's qualifications, including information that would enable the Department of the Interior to make an informed decision regarding meeting the membership requirements of the Committee and permit the Department to contact a potential member. All documentation, including letters of recommendation, must be compiled and submitted in one complete package. All those interested in membership, including current members whose terms are expiring, must follow the same nomination process. Members may not appoint deputies or alternates.
Members of the Committee serve without compensation. However, while away from their homes or regular places of business in the performance of services for the Committee as approved by the NPS, members may be allowed travel expenses, including per diem in lieu of subsistence, in the same manner as persons employed intermittently in Government service are allowed such expenses under section 5703 of title 5 of the United States Code.
54 U.S.C. 100906.
United States International Trade Commission.
Notice.
October 15, 2018.
Eric Daugherty ((202) 205-2078), Office of Investigations, U.S. International Trade Commission, 500 E Street SW, Washington, DC 20436. Hearing-impaired persons can obtain information on this matter by contacting the Commission's TDD terminal on 202-205-1810. Persons with mobility impairments who will need special assistance in gaining access to the Commission should contact the Office of the Secretary at 202-205-2000. General information concerning the Commission may also be obtained by accessing its internet server (
Effective July 10, 2018, the Commission established a schedule for the conduct of this review (83 FR 33250, July 17,
For further information concerning this review see the Commission's notice cited above and the Commission's Rules of Practice and Procedure, part 201, subparts A through E (19 CFR part 201), and part 207, subparts A and C (19 CFR part 207).
By order of the Commission.
October 25, 2018 at 11:00 a.m.
Room 101, 500 E Street SW, Washington, DC 20436, Telephone: (202) 205-2000.
Open to the public.
1. Agendas for future meetings: None.
2. Minutes.
3. Ratification List.
4. Vote in Inv. No. 731-TA-1110 (Second Review) (Sodium Hexametaphosphate from China). The Commission is currently scheduled to complete and file its determination and views of the Commission by November 15, 2018.
5. Outstanding action jackets: None.
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.
United States International Trade Commission.
Notice.
October 17, 2018
Celia Feldpausch (202-205-2387), Office of Investigations, U.S. International Trade Commission, 500 E Street SW, Washington, DC 20436. Hearing-impaired persons can obtain information on this matter by contacting the Commission's TDD terminal on 202-205-1810. Persons with mobility impairments who will need special assistance in gaining access to the Commission should contact the Office of the Secretary at 202-205-2000. General information concerning the Commission may also be obtained by accessing its internet server (
Effective May 17, 2018, the Commission established a general schedule for the conduct of the final phase of its investigations on forged steel fittings from China, Italy, and Taiwan,
This supplemental schedule is as follows: The deadline for filing supplemental party comments on Commerce's final antidumping and countervailing duty determinations is October 19, 2018. Supplemental party comments may address only Commerce's final antidumping and countervailing duty determinations regarding imports of forged steel fittings from China and Italy. These supplemental final comments may not contain new factual information and may not exceed five (5) pages in length. The supplemental staff report in the final phase of these investigations regarding subject imports from China and Italy will be placed in the nonpublic record on October 30, 2018; and a public version will be issued thereafter.
For further information concerning these investigations see the Commission's notice cited above and the Commission's Rules of Practice and Procedure, part 201, subparts A and B (19 CFR part 201), and part 207, subparts A and C (19 CFR part 207).
Additional written submissions to the Commission, including requests pursuant to section 201.12 of the Commission's rules, shall not be accepted unless good cause is shown for accepting such submissions, or unless the submission is pursuant to a specific request by a Commissioner or Commission staff.
In accordance with sections 201.16(c) and 207.3 of the Commission's rules, each document filed by a party to the investigations must be served on all other parties to the investigations (as identified by either the public or BPI service list), and a certificate of service must be timely filed. The Secretary will not accept a document for filing without a certificate of service.
By order of the Commission.
U.S. International Trade Commission.
Notice.
Notice is hereby given that the presiding administrative law judge has issued a Final Initial Determination on Section 337 Violation and a Recommended Determination on Remedy and Bonding in the above-captioned investigation. The Commission is soliciting comments on public interest issues raised by the recommended relief, should the Commission find a violation. This notice is soliciting public interest comments from the public only. Parties are to file public interest submissions pursuant to Commission rules.
Michael Liberman, Office of the General Counsel, U.S. International Trade Commission, 500 E Street SW, Washington, DC 20436, telephone (202) 205-3115. Copies of non-confidential documents filed in connection with this investigation are or will be available for inspection during official business hours (8:45 a.m. to 5:15 p.m.) in the Office of the Secretary, U.S. International Trade Commission, 500 E Street SW, Washington, DC 20436, telephone (202) 205-2000. General information concerning the Commission may also be obtained by accessing its internet server (
Section 337 of the Tariff Act of 1930 (“Section 337”) provides that if the Commission finds a violation it shall exclude the articles concerned from the United States unless the public interest factors listed in 19 U.S.C. 1337(d)(1) prevent such action. A similar provision applies to cease and desist orders. 19 U.S.C. 1337(f)(1).
The Commission is soliciting comments on public interest issues raised by the recommended relief should the Commission find a violation, specifically: (1) A limited exclusion order (“LEO”) against certain road milling machines and components thereof, which are imported, sold for importation, and/or sold after importation by respondent Caterpillar Prodotti Stradali S.r.L.; Caterpillar Americas CV; Caterpillar Paving Products, Inc.; and Caterpillar Inc. (“Caterpillar”); and (2) a cease and desist order (“CDO”) against Caterpillar.
The Commission is interested in further development of the record on the public interest in this investigation. Accordingly, parties are to file public interest submissions pursuant to 19 CFR 210.50(a)(4). In addition, members of the public are hereby invited to file submissions of no more than five (5) pages, inclusive of attachments, concerning the public interest in light of the administrative law judge's Recommended Determination on Remedy and Bonding issued in this investigation on October 15, 2018. Comments should address whether issuance of the LEO and CDO in this investigation, should the Commission find a violation, would affect the public health and welfare in the United States, competitive conditions in the United States economy, the production of like or directly competitive articles in the United States, or United States consumers.
In particular, the Commission is interested in comments that:
(i) Explain how the articles potentially subject to the recommended orders are used in the United States;
(ii) Identify any public health, safety, or welfare concerns in the United States relating to the recommended orders;
(iii) Identify like or directly competitive articles that complainants, their licensees, or third parties make in the United States which could replace the subject articles if they were to be excluded;
(iv) Indicate whether complainants, complainants' licensees, and/or third party suppliers have the capacity to replace the volume of articles potentially subject to the recommended exclusion order and/or a cease and desist order within a commercially reasonable time; and
(v) Explain how the LEO and CDO would impact consumers in the United States.
Written submissions from the public must be filed no later than by close of business on Friday, November 9, 2018.
Persons filing written submissions must file the original document electronically on or before the deadlines stated above and submit 8 true paper copies to the Office of the Secretary by noon the next day pursuant to section 210.4(f) of the Commission's Rules of Practice and Procedure (19 CFR 210.4(f)). Submissions should refer to the investigation number (“Inv. No. 337-TA-1067”) in a prominent place on the cover page and/or the first page. (
The authority for the Commission's determination is contained in section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and in part 210 of the Commission's Rules of Practice and Procedure (19 CFR part 210).
By order of the Commission.
Notice is hereby given that, on October 10, 2018, pursuant to Section 6(a) of the National Cooperative Research and Production Act of 1993, 15 U.S.C. 4301
On September 20, 2004, NFPA 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 July 31, 2018. A notice was published in the
On October 15, 2018, the Department of Justice lodged a proposed consent decree with the United States District Court for the Eastern District of Michigan in the lawsuit entitled
The United States filed this lawsuit under the Comprehensive Environmental Response, Compensation, and Liability Act. The United States' complaint seeks recovery of EPA's past response costs for the cleanup of the Shoemaker Street Superfund Site in Detroit, Michigan. The consent decree requires the defendant to pay $425,000 of EPA's past response costs. Upon payment, the defendant will receive a covenant not to sue for any EPA response costs related to the Site that predate the entry of the consent decree.
The publication of this notice opens a period for public comment on the consent decree. Comments should be addressed to the Assistant Attorney General, Environment and Natural Resources Division, and should refer to
During the public comment period, the consent decree may be examined and downloaded at this Justice Department website:
Please enclose a check or money order for $3.50 (25 cents per page reproduction cost) payable to the United States Treasury.
In accordance with the Section 223 (19 U.S.C. 2273) of the Trade Act of 1974 (19 U.S.C. 2271,
In order for an affirmative determination to be made for workers of a primary firm and a certification issued regarding eligibility to apply for TAA, the group eligibility requirements under Section 222(a) of the Act (19 U.S.C. 2272(a)) must be met, as follows:
(1) The first criterion (set forth in Section 222(a)(1) of the Act, 19 U.S.C. 2272(a)(1)) is that a significant number or proportion of the workers in such workers' firm (or “such firm”) have become totally or partially separated, or are threatened to become totally or partially separated;
(2) The second criterion (set forth in Section 222(a)(2) of the Act, 19 U.S.C. 2272(a)(2)) may be satisfied by either (A) the Increased Imports Path, or (B) the Shift in Production or Services to a Foreign Country Path/Acquisition of Articles or Services from a Foreign Country Path, as follows:
(i) The sales or production, or both, of such firm, have decreased absolutely;
(ii)(I) imports of articles or services like or directly competitive with articles produced or services supplied by such firm have increased; OR
(II)(aa) imports of articles like or directly competitive with articles into which one or more component parts produced by such firm are directly incorporated, have increased; OR
(II)(bb) imports of articles like or directly competitive with articles which are produced directly using the services supplied by such firm, have increased; OR
(III) imports of articles directly incorporating one or more component parts produced outside the United States that are like or directly competitive with imports of articles incorporating one or more component parts produced by such firm have increased;
(iii) the increase in imports described in clause (ii) contributed importantly to such workers' separation or threat of separation and to the decline in the sales or production of such firm; OR
(i)(I) There has been a shift by such workers' firm to a foreign country in the production of articles or the supply of services like or directly competitive with articles which are produced or services which are supplied by such firm; OR
(II) such workers' firm has acquired from a foreign country articles or services that are like or directly competitive with articles which are produced or services which are supplied by such firm;
(ii) the shift described in clause (i)(I) or the acquisition of articles or services described in clause (i)(II) contributed importantly to such workers' separation or threat of separation.
In order for an affirmative determination to be made for adversely affected secondary workers of a firm and a certification issued regarding eligibility to apply for TAA, the group eligibility requirements of Section 222(b) of the Act (19 U.S.C. 2272(b)) must be met, as follows:
(1) A significant number or proportion of the workers in the workers' firm or an appropriate subdivision of the firm have become totally or partially separated, or are threatened to become totally or partially separated;
(2) the workers' firm is a supplier or downstream producer to a firm that employed a group of workers who received a certification of eligibility under Section 222(a) of the Act (19 U.S.C. 2272(a)), and such supply or production is related to the article or service that was the basis for such certification (as defined in subsection 222(c)(3) and (4) of the Act (19 U.S.C. 2272(c)(3) and (4));
(3) either—
(A) the workers' firm is a supplier and the component parts it supplied to the firm described in paragraph (2) accounted for at least 20 percent of the production or sales of the workers' firm; OR
(B) a loss of business by the workers' firm with the firm described in paragraph (2) contributed importantly to the workers' separation or threat of separation determined under paragraph (1).
In order for an affirmative determination to be made for adversely affected workers in firms identified by the International Trade Commission and a certification issued regarding eligibility to apply for TAA, the group eligibility requirements of Section 222(e) of the Act (19 U.S.C. 2272(e))must be met, by following criteria (1), (2), and (3) as follows:
(1) The workers' firm is publicly identified by name by the International Trade Commission as a member of a domestic industry in an investigation resulting in—
(A) an affirmative determination of serious injury or threat thereof under section 202(b)(1) of the Act (19 U.S.C. 2252(b)(1)); OR
(B) an affirmative determination of market disruption or threat thereof under section 421(b)(1) of the Act (19 U.S.C. 2436(b)(1)); OR
(C) an affirmative final determination of material injury or threat thereof under section 705(b)(1)(A) or 735(b)(1)(A) of the Tariff Act of 1930 (19 U.S.C. 1671d(b)(1)(A) and 1673d(b)(1)(A));
(2) the petition is filed during the 1-year period beginning on the date on which—
(A) a summary of the report submitted to the President by the International Trade Commission under section 202(f)(1) of the Trade Act (19 U.S.C. 2252(f)(1)) with respect to the affirmative determination described in paragraph (1)(A) is published in the
(B) notice of an affirmative determination described in subparagraph (B) or (C) of paragraph (1) is published in the
(3) the workers have become totally or partially separated from the workers' firm within—
(A) the 1-year period described in paragraph (2); OR
(B) notwithstanding section 223(b) of the Act (19 U.S.C. 2273(b)), the 1-year period preceding the 1-year period described in paragraph (2).
The following certifications have been issued. The date following the company name and location of each determination references the impact date for all workers of such determination.
The following certifications have been issued. The requirements of Section 222(a)(2)(A) (Increased Imports Path) of the Trade Act have been met.
The following certifications have been issued. The requirements of Section 222(a)(2)(B) (Shift in Production or Services to a Foreign Country Path or Acquisition of Articles or Services from a Foreign Country Path) of the Trade Act have been met.
The following certifications have been issued. The requirements of Section 222(b) (supplier to a firm whose workers are certified eligible to apply for TAA) of the Trade Act have been met.
The following certifications have been issued. The requirements of Section 222(e) (firms identified by the International Trade Commission) of the Trade Act have been met.
In the following cases, the investigation revealed that the eligibility criteria for TAA have not been met for the reasons specified.
The investigation revealed that the requirements of Trade Act section 222(a)(1) and (b)(1) (significant worker total/partial separation or threat of total/partial separation), or (e) (firms identified by the International Trade Commission), have not been met.
The investigation revealed that the criteria under paragraphs (a)(2)(A) (increased imports), (a)(2)(B) (shift in production or services to a foreign country or acquisition of articles or services from a foreign country), (b)(2) (supplier to a firm whose workers are certified eligible to apply for TAA or downstream producer to a firm whose workers are certified eligible to apply for TAA), and (e) (International Trade Commission) of section 222 have not been met.
After notice of the petitions was published in the
The following determinations terminating investigations were issued because the petitioner has requested that the petition be withdrawn.
The following determinations terminating investigations were issued in cases where the petition regarding the investigation has been deemed invalid.
The following determinations terminating investigations were issued because the worker group on whose behalf the petition was filed is covered under an existing certification.
The following determinations terminating investigations were issued because the petitioning group of workers is covered by an earlier petition that is the subject of an ongoing investigation for which a determination has not yet been issued.
I hereby certify that the aforementioned determinations were issued during the period of July 14, 2018 through August 17, 2018. These determinations are available on the Department's website
In accordance with Sections 223 and 284 (19 U.S.C. 2273 and 2395) of the Trade Act of 1974 (19 U.S.C. 2271,
The certifying officer may grant an application for reconsideration under the following circumstances: (1) If it appears on the basis of facts not previously considered that the determination complained of was
The following Applications for Reconsideration have been received and granted. See 29 CFR 90.18(d). The group of workers or other persons showing an interest in the proceedings may provide written submissions to show why the determination under reconsideration should or should not be modified. The submissions must be sent no later than ten days after publication in the
The following determinations regarding applications for reconsideration have been received and denied. The determination complained of was not erroneous; there was not a mistake in the determination of facts previously considered; and in the opinion of the certifying officer, there was not a misinterpretation of facts or of the law justifying reconsideration of the determination. A Negative Determination Regarding Application for Reconsideration is a final determination for purposes of judicial review pursuant to section 284 of the Act (19 U.S.C. 2395) and 29 CFR 90.19(a).
Revised certifications of eligibility have been issued with respect to cases where affirmative determinations and certificates of eligibility were issued initially, but a minor error was discovered after the certification was issued. The revised certifications are issued pursuant to the Secretary's authority under section 223 of the Act and 29 CFR 90.16. Revised Certifications of Eligibility are final determinations for purposes of judicial review pursuant to section 284 of the Act (19 U.S.C. 2395) and 29 CFR 90.19(a).
Post-initial determinations have been issued with respect to cases where affirmative determinations regarding applications for reconsideration were granted. For cases where the worker group eligibility requirements are met, Revised Certifications of Eligibility or Revised Determinations have been issued. Revised Certifications of Eligibility and Revised Determinations are final determinations for purposes of judicial review pursuant to section 284 of the Act (19 U.S.C. 2395) and 29 CFR 90.19(a).
Post-initial determinations have also been issued with respect to cases where negative determinations regarding eligibility to apply for TAA were issued initially or on reconsideration and were appealed to the Court of International Trade and remanded by the court to the Secretary for the taking of additional evidence. See 29 CFR 90.19(a) and (c). For cases where the worker group eligibility requirements are met, the previous determination was modified and Revised Determinations on Remand have been issued. For cases where the worker group eligibility requirements are not met, the previous determination is affirmed and Negative Determinations on Remand have been issued. The Secretary will certify and file the record of the remand proceedings in the Court of International Trade. Determinations on Remand are final determinations for purposes of judicial review pursuant to section 284 of the Act (19 U.S.C. 2395).
(This Notice primarily follows the language of the Trade Act. In some places however, changes such as the inclusion of subheadings, a reorganization of language, or “and,” “or,” or other words are added for clarification.)
In order for an affirmative determination to be made for workers of a primary firm and a certification issued regarding eligibility to apply for TAA, the group eligibility requirements under Section 222(a) of the Act (19 U.S.C. 2272(a)) must be met, as follows:
(1) The first criterion (set forth in Section 222(a)(1) of the Act, 19 U.S.C. 2272(a)(1)) is that a significant number or proportion of the workers in such workers' firm (or “such firm”) have become totally or partially separated, or are threatened to become totally or partially separated;
AND (2(A) or 2(B) below).
(2) The second criterion (set forth in Section 222(a)(2) of the Act, 19 U.S.C. 2272(a)(2)) may be satisfied by either (A) the Increased Imports Path, or (B) the Shift in Production or Services to a Foreign Country Path/Acquisition of Articles or Services from a Foreign Country Path, as follows:
(A) Increased Imports Path:
(i) the sales or production, or both, of such firm, have decreased absolutely;
AND (ii and iii below).
(ii) (I) imports of articles or services like or directly competitive with articles produced or services supplied by such firm have increased; OR
(II)(aa) imports of articles like or directly competitive with articles into which one or more component parts produced by such firm are directly incorporated, have increased; OR
(II)(bb) imports of articles like or directly competitive with articles which are produced directly using the services supplied by such firm, have increased; OR
(III) imports of articles directly incorporating one or more component parts produced outside the United States that are like or directly competitive with imports of articles incorporating one or more component parts produced by such firm have increased;
AND
(iii) the increase in imports described in clause (ii) contributed importantly to such workers' separation or threat of separation and to the decline in the sales or production of such firm; OR
(B) Shift in Production or Services to a Foreign Country Path OR Acquisition of Articles or Services from a Foreign Country Path:
(i)(I) there has been a shift by such workers' firm to a foreign country in the production of articles or the supply of services like or directly competitive with articles which are produced or services which are supplied by such firm; OR
(II) such workers' firm has acquired from a foreign country articles or services that are like or directly competitive with articles which are produced or services which are supplied by such firm;
AND
(ii) the shift described in clause (i)(I) or the acquisition of articles or services described in clause (i)(II) contributed
In order for an affirmative determination to be made for adversely affected secondary workers of a firm and a certification issued regarding eligibility to apply for TAA, the group eligibility requirements of Section 222(b) of the Act (19 U.S.C. 2272(b)) must be met, as follows:
(1) a significant number or proportion of the workers in the workers' firm or an appropriate subdivision of the firm have become totally or partially separated, or are threatened to become totally or partially separated;
AND
(2) the workers' firm is a supplier or downstream producer to a firm that employed a group of workers who received a certification of eligibility under Section 222(a) of the Act (19 U.S.C. 2272(a)), and such supply or production is related to the article or service that was the basis for such certification (as defined in subsection 222(c)(3) and (4) of the Act (19 U.S.C. 2272(c)(3) and (4));
AND
(3) either—
(A) the workers' firm is a supplier and the component parts it supplied to the firm described in paragraph (2) accounted for at least 20 percent of the production or sales of the workers' firm; OR
(B) a loss of business by the workers' firm with the firm described in paragraph (2) contributed importantly to the workers' separation or threat of separation determined under paragraph (1).
Section 222(e)—Firms identified by the International Trade Commission
In order for an affirmative determination to be made for adversely affected workers in firms identified by the International Trade Commission and a certification issued regarding eligibility to apply for TAA, the group eligibility requirements of Section 222(e) of the Act (19 U.S.C. 2272(e) must be met, by following criteria (1), (2), and (3) as follows:
(1) the workers' firm is publicly identified by name by the International Trade Commission as a member of a domestic industry in an investigation resulting in—
(A) an affirmative determination of serious injury or threat thereof under section 202(b)(1) of the Act (19 U.S.C. 2252(b)(1)); OR
(B) an affirmative determination of market disruption or threat thereof under section 421(b)(1) of the Act (19 U.S.C. 2436(b)(1)); OR
(C) an affirmative final determination of material injury or threat thereof under section 705(b)(1)(A) or 735(b)(1)(A) of the Tariff Act of 1930 (19 U.S.C. 1671d(b)(1)(A) and 1673d(b)(1)(A));
AND
(2) the petition is filed during the 1-year period beginning on the date on which—
(A) a summary of the report submitted to the President by the International Trade Commission under section 202(f)(1) of the Trade Act (19 U.S.C. 2252(f)(1)) with respect to the affirmative determination described in paragraph (1)(A) is published in the
(B) notice of an affirmative determination described in subparagraph (B) or (C) of paragraph (1) is published in the
AND
(3) the workers have become totally or partially separated from the workers' firm within—
(A) the 1-year period described in paragraph (2); OR
(B) notwithstanding section 223(b) of the Act (19 U.S.C. 2273(b)), the 1-year period preceding the 1-year period described in paragraph (2).
The following revised certifications of eligibility to apply for TAA have been issued. The date following the company name and location of each determination references the impact date for all workers of such determination, and the reason(s) for the determination.
The following revisions have been issued.
The following revised determinations on reconsideration, certifying eligibility to apply for TAA, have been issued. The date following the company name and location of each determination references the impact date for all workers of such determination.
The following revised determinations on reconsideration, certifying eligibility to apply for TAA, have been issued. The requirements of Section 222(a)(2)(A)
The following revised determinations on reconsideration, certifying eligibility to apply for TAA, have been issued. The requirements of Section 222(a)(2)(B) (Shift in Production or Services to a Foreign Country Path or Acquisition of Articles or Services from a Foreign Country Path) of the Trade Act have been met.
The following revised determinations on reconsideration, certifying eligibility to apply for TAA, have been issued. The requirements of Section 222(b) (supplier to a firm whose workers are certified eligible to apply for TAA) of the Trade Act have been met.
In the following cases, negative determinations on reconsideration have been issued because the eligibility criteria for TAA have not been met for the reason(s) specified.
The investigation revealed that the criteria under Trade Act section 222 (a)(2)(A)(i) (decline in sales or production, or both), (a)(2)(B) (shift in production or services to a foreign country or acquisition of articles or services from a foreign country), (b)(2) (supplier to a firm whose workers are certified eligible to apply for TAA or downstream producer to a firm whose workers are certified eligible to apply for TAA), (b)(3)(component parts supplied accounted for at least 20% of production/sales, or loss of business with firm contributed importantly to worker separation or threat of separation), and (e) (International Trade Commission) have not been met.
The investigation revealed that the criteria under Trade Act section 222(a)(2)(A) (increased imports), (a)(2)(B) (shift in production or services to a foreign country or acquisition of articles or services from a foreign
The following revised determinations on remand, certifying eligibility to apply for TAA, have been issued. The date following the company name and location of each determination references the impact date for all workers of such determination and the reason(s) for the determination.
The following revised determinations on remand, certifying eligibility to apply for TAA, have been issued. The requirements of Section 222(a)(2)(A) (Increased Imports Path) of the Trade Act have been met.
The following revised determinations on remand, certifying eligibility to apply for TAA, have been issued. The requirements of Section 222(b) (supplier to a firm whose workers are certified eligible to apply for TAA) of the Trade Act have been met.
In the following cases, negative determinations on remand have been issued because the eligibility criteria for TAA have not been met for the reason(s) specified.
The investigation revealed that the requirements of Trade Act Section 222 (a)(1) and (b)(1) (significant worker total/partial separation or threat of total/partial separation), or (e) (firms identified by the International Trade Commission) have not been met.
The investigation revealed that the criteria under Trade Act section 222 (a)(2)(A)(i) (decline in sales or production, or both), (a)(2)(B) (shift in production or services to a foreign country or acquisition of articles or services from a foreign country), (b)(2) (supplier to a firm whose workers are certified eligible to apply for TAA or downstream producer to a firm whose workers are certified eligible to apply for TAA), (b)(3)(component parts supplied accounted for at least 20% of production/sales, or loss of business with firm contributed importantly to worker separation or threat of separation), and (e) (International Trade Commission) have not been met.
The investigation revealed that the criteria under Trade Act section 222(a)(2)(A) (increased imports), (a)(2)(B) (shift in production or services to a foreign country or acquisition of articles or services from a foreign country), (b)(2) (supplier to a firm whose workers are certified eligible to apply for TAA or downstream producer to a firm whose workers are certified eligible to apply for TAA), and (e) (International Trade Commission) have not been met.
Petitions have been filed with the Secretary of Labor under Section 221 (a) of the Trade Act of 1974 (“the Act”) and are identified in the Appendix to this notice. Upon receipt of these petitions, the Director of the Office of Trade Adjustment Assistance, Employment and Training Administration, has instituted investigations pursuant to Section 221 (a) of the Act.
The purpose of each of the investigations is to determine whether the workers are eligible to apply for adjustment assistance under Title II, Chapter 2, of the Act. The investigations will further relate, as appropriate, to the determination of the date on which total or partial separations began or threatened to begin and the subdivision of the firm involved.
The petitioners or any other persons showing a substantial interest in the subject matter of the investigations may request a public hearing provided such request is filed in writing with the Director, Office of Trade Adjustment Assistance, at the address shown below, no later than November 1, 2018.
Interested persons are invited to submit written comments regarding the subject matter of the investigations to the Director, Office of Trade Adjustment Assistance, at the address shown below, not later than November 1, 2018.
The petitions filed in this case are available for inspection at the Office of the Director, Office of Trade Adjustment Assistance, Employment and Training Administration, U.S. Department of Labor, Room N-5428, 200 Constitution Avenue NW, Washington, DC 20210.
Occupational Safety and Health Administration (OSHA), Labor.
Notice; announcement of the Office of Management and Budget's (OMB) approval of information collection requirements.
The Occupational Safety and Health Administration announces that OMB extended its approval for a number of information collection requirements found in a number of OSHA's standards and regulations. OSHA sought approval of these
This notice is applicable October 22, 2018.
Seleda Perryman or Theda Kenney, Directorate of Standards and Guidance, OSHA, U.S. Department of Labor, telephone (202) 693-2222.
In a series of
In accordance with the PRA (44 U.S.C. 3501-3520), OMB approved these information collection requirements. The table below provides the following information for each of these requirements approved by OMB: the title of the
In accordance with 5 CFR 1320.5(b), an agency cannot conduct, sponsor, or require a response to a collection of information unless the collection displays a valid OMB control number and the agency informs respondents that they need not respond to the collection of information.
Loren Sweatt, Deputy Assistant Secretary of Labor for Occupational Safety and Health, directed the preparation of this notice. The authority for this notice is the Paperwork Reduction Act of 1995 (44 U.S.C. 3506
National Aeronautics and Space Administration (NASA).
Notice of information collection.
The National Aeronautics and Space Administration, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections.
All comments should be submitted within 30 calendar days from the date of this publication.
All comments should be addressed to Gatrie Johnson, National Aeronautics and Space Administration, 300 E Street SW, Washington, DC 20546-0001 or email
Requests for additional information or copies of the information collection instrument(s) and instructions should be directed to Gatrie Johnson, NASA Clearance Officer, NASA Headquarters, 300 E Street SW, JF0000, Washington, DC 20546 or email
A federal grant is an award of financial assistance from a federal agency to a recipient to carry out a public purpose of support or stimulation authorized by a law of the United States. The NASA Procurement Office supports NASA research, science, and education communities through the award of research/education/and training grants in the science, technology, engineering, and math (STEM) fields. NASA has a continuing commitment to identify and address inequities associated with its grant review and awards processes. To support that commitment, NASA implemented a process to collect demographic data from grant applicants for the purpose of analyzing demographic differences associated with its award processes. Information collected includes the name, gender, race, ethnicity, disability status, citizenship status, education, and career data of the respondents.
Submission of the information is voluntary and is not a precondition of award. However, if the information is not submitted, it will undermine the usefulness of information received from other respondents.
Electronic.
Comments are invited on: (1) Whether the proposed collection of information is necessary for the proper performance of the functions of NASA, including whether the information collected has practical utility; (2) the accuracy of NASA's estimate of the burden (including hours and cost) of the proposed collection of information; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including automated collection techniques or the use of other forms of information technology.
Comments submitted in response to this notice will be summarized and included in the request for OMB approval of this information collection. They will also become a matter of public record.
Nuclear Regulatory Commission.
Exemption and combined license amendment; issuance.
The U.S. Nuclear Regulatory Commission (NRC) is granting an exemption to allow a departure from the certification information of Tier 1 of the generic design control document (DCD) and is issuing License Amendment Nos. 140 and 139 to Combined Licenses (COLs), NPF-91 and NPF-92, respectively. The COLs were issued to Southern Nuclear Operating Company, Inc., and Georgia Power Company, Oglethorpe Power Corporation, MEAG Power SPVM, LLC, MEAG Power SPVJ, LLC, MEAG Power SPVP, LLC, and the City of Dalton, Georgia (collectively SNC); for construction and operation of the Vogtle Electric Generating Plant (VEGP) Units 3 and 4, located in Burke County, Georgia.
The granting of the exemption allows the changes to Tier 1 information asked for in the amendment. Because the acceptability of the exemption was determined in part by the acceptability of the amendment, the exemption and amendment are being issued concurrently.
The exemption and amendment were issued on August 24, 2018.
Please refer to Docket ID NRC-2008-0252 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:
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Chandu Patel, Office of New Reactors, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-3025; email:
The NRC is granting an exemption from paragraph B of section III, “Scope and Contents,” of appendix D, “Design Certification Rule for the AP1000,” to part 52 of title 10 of the
Part of the justification for granting the exemption was provided by the review of the amendment. Because the exemption is necessary in order to issue the requested license amendment, the NRC granted the exemption and issued the amendment concurrently, rather than in sequence. This included issuing a combined safety evaluation containing the NRC staff's review of both the exemption request and the license amendment. The exemption met all applicable regulatory criteria set forth in 10 CFR 50.12, 52.7, and section VIII.A.4 of appendix D to 10 CFR part 52. The license amendment was found to be acceptable as well. The combined safety evaluation is available in ADAMS under Accession No. ML18220B104.
Identical exemption documents (except for referenced unit numbers and license numbers) were issued to SNC for VEGP Units 3 and 4 (COL Nos. NPF-91 and NPF-92). The exemption documents for VEGP Units 3 and 4 can be found in ADAMS under Accession Nos. ML18220B097 and ML18220B098, respectively. The exemption is reproduced (with the exception of abbreviated titles and additional citations) in Section II of this document. The amendment documents for COL Nos. NPF-91 and NPF-92 are available in ADAMS under Accession Nos. ML18220B099 and ML18220B100, respectively. A summary of the amendment documents is provided in Section III of this document.
Reproduced below is the exemption document issued to VEGP Units 3 and 4. It makes reference to the combined safety evaluation that provides the reasoning for the findings made by the NRC (and listed under Item 1) in order to grant the exemption:
1. In a letter dated April 26, 2018, SNC requested from the Commission an exemption to allow departures from Tier 1 information in the certified DCD incorporated by reference in 10 CFR part 52, appendix D, as part of license amendment request 18-014, “Containment Sump Level Instrumentation.”
For the reasons set forth in Section 3.1 [sic] of the NRC staff's Safety Evaluation, which can be found in ADAMS under Accession No. ML18220B104, the Commission finds that:
A. The exemption is authorized by law;
B. the exemption presents no undue risk to public health and safety;
C. the exemption is consistent with the common defense and security;
D. special circumstances are present in that the application of the rule in this circumstance is not necessary to serve the underlying purpose of the rule;
E. the special circumstances outweigh any decrease in safety that may result from the reduction in standardization caused by the exemption; and
F. the exemption will not result in a significant decrease in the level of safety otherwise provided by the design.
2. Accordingly, the licensee is granted an exemption from the certified DCD Tier 1 information, with corresponding changes to Appendix C of the Facility Combined Licenses as described in the licensee's request dated April 26, 2018. This exemption is related to, and necessary for the granting of License Amendment No. 140 [for Unit 3 and No. 139 for Unit 4], which is being issued concurrently with this exemption.
3. As explained in Section 5.0 of the NRC staff's Safety Evaluation (ADAMS Accession No. ML18220B104), this exemption meets the eligibility criteria for categorical exclusion set forth in 10 CFR 51.22(c)(9). Therefore, pursuant to 10 CFR 51.22(b), no environmental impact statement or environmental assessment needs to be prepared in connection with the issuance of the exemption.
4. This exemption is effective as of the date of its issuance.
By letter dated April 26, 2018 (ADAMS Accession No. ML18116A138), SNC requested that the NRC amend the COLs for VEGP, Units 3 and 4, COLs NPF-91 and NPF-92. The proposed amendment is described in Section I of this
The Commission has determined for these amendments that the application complies with the standards and requirements of the Atomic Energy Act of 1954, as amended (the Act), and the Commission's rules and regulations. The Commission has made appropriate findings as required by the Act and the Commission's rules and regulations in 10 CFR chapter I, which are set forth in the license amendment.
A notice of consideration of issuance of amendment to facility operating license or COL, as applicable, proposed no significant hazards consideration determination, and opportunity for a hearing in connection with these actions, was published in the
The Commission has determined that these amendments satisfy the criteria for categorical exclusion in accordance with 10 CFR 51.22. Therefore, pursuant to 10 CFR 51.22(b), no environmental impact statement or environmental assessment need be prepared for these amendments.
Using the reasons set forth in the combined safety evaluation, the staff
For the Nuclear Regulatory Commission.
Nuclear Regulatory Commission.
Exemption; issuance.
The U.S. Nuclear Regulatory Commission (NRC) has issued exemptions in response to a request from Exelon Generation Company, LLC (Exelon or the licensee) regarding certain emergency planning (EP) requirements. The exemptions eliminate the requirements to maintain an offsite radiological emergency preparedness plan and reduce the scope of onsite EP activities at the Oyster Creek Nuclear Generating Station (Oyster Creek), based on the reduced risks of accidents that could result in an offsite radiological release at a decommissioning nuclear power reactor.
The exemption was issued on October 16, 2018.
Please refer to Docket ID NRC-2018-0167 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:
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John G. Lamb, Office of Nuclear Reactor Regulation, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-3100; email:
The text of the exemption is attached.
The documents identified in the following table are available for public inspection through ADAMS, a public web page, or by using one of the methods discussed in the
For the Nuclear Regulatory Commission.
Exelon Generation Company, LLC (Exelon or the licensee) is the holder of Renewed Facility Operating License No. DPR-16 for Oyster Creek Nuclear Generating Station (Oyster Creek). The license provides, among other things, that the facility is subject to all rules, regulations, and orders of the U.S. Nuclear Regulatory Commission (NRC) now or hereafter in effect. The facility consists of a boiling-water reactor (BWR) located in Ocean County, New Jersey.
By letter dated February 14, 2018 (Agencywide Documents Access and Management System (ADAMS) Accession No. ML18045A084), Exelon submitted a certification to the NRC that it would permanently cease power operations at Oyster Creek no later than October 31, 2018. On September 17, 2018, Exelon permanently ceased power operations at Oyster Creek. By letter dated September 25, 2018 (ADAMS Accession No. ML18268A258), Exelon certified the permanent removal of fuel from the Oyster Creek reactor vessel.
In accordance with § 50.82(a)(2) of Title 10 of the
During normal power reactor operations, the forced flow of water through the reactor coolant system removes heat generated by the reactor. The reactor coolant system, operating at high temperatures and pressures, transfers this heat through the steam generator tubes converting non-radioactive feedwater to steam, which then flows to the main turbine generator to produce electricity. Many of the accident scenarios postulated in the updated safety analysis reports (USARs) for operating power reactors involve failures or malfunctions of systems, which could affect the fuel in the reactor core and, in the most severe postulated accidents, would involve the release of large quantities of fission products. With the permanent cessation of operations at Oyster Creek and the permanent removal of the fuel from the reactor vessel, such accidents are no longer possible. The reactor, reactor coolant system, and supporting systems are no longer in operation and have no function related to the storage of the spent fuel. Therefore, emergency planning (EP) provisions for postulated accidents involving failure or malfunction of the reactor, reactor coolant system, or supporting systems are no longer applicable.
The EP requirements of 10 CFR 50.47, “Emergency plans,” and Appendix E to 10 CFR part 50, “Emergency Planning and Preparedness for Production and Utilization Facilities,” continue to apply to nuclear power reactors that have permanently ceased operation and have permanently removed all fuel from the reactor vessel. There are no explicit regulatory provisions distinguishing EP requirements for a power reactor that is permanently shut down and defueled from those for a reactor that is authorized to operate. To reduce or eliminate EP requirements that are no longer necessary due to the decommissioning status of the facility, Exelon must obtain exemptions from those EP regulations. Only then can Exelon modify the Oyster Creek emergency plan to reflect the reduced risk associated with the permanently shutdown and defueled condition of Oyster Creek.
By letter dated August 22, 2017 (ADAMS Accession No. ML17234A082), Exelon requested exemptions from certain EP requirements of 10 CFR part 50 for Oyster Creek. Specifically, Exelon requested exemptions from certain planning standards in 10 CFR 50.47(b) regarding onsite and offsite radiological emergency preparedness plans for nuclear power reactors, from certain requirements in 10 CFR 50.47(c)(2) for establishment of plume exposure and ingestion pathway emergency planning zones for nuclear power reactors; and from certain requirements in 10 CFR part 50, Appendix E, Section IV, which establishes the elements that make up the content of emergency plans. In letters dated December 6, 2017, and January 23, March 8, and March 19, 2018 (ADAMS Accession Nos. ML17340A708, ML18023A138, ML18067A087, and ML18078A146, respectively), Exelon provided supplemental information and responses to the NRC staff's requests for additional information concerning the proposed exemptions.
The information provided by Exelon included justifications for each exemption requested. The exemptions requested by Exelon would eliminate the requirements to maintain formal offsite radiological emergency preparedness plans reviewed by the Federal Emergency Management Agency (FEMA) under the requirements of 44 CFR part 350 and would reduce the scope of onsite EP activities at Oyster Creek. The licensee stated that the application of all of the standards and requirements in 10 CFR 50.47(b), 10 CFR 50.47(c), and 10 CFR part 50, Appendix E is not needed for adequate emergency response capability, based on the substantially lower onsite and offsite radiological consequences of accidents still possible at the permanently shutdown and defueled facility, as compared to an operating facility. If offsite protective actions were needed for a highly unlikely beyond-design-basis accident that could challenge the safe storage of spent fuel at Oyster Creek, provisions exist for offsite agencies to take protective actions using a comprehensive emergency management plan (CEMP) under the National Preparedness System to protect the health and safety of the public. A CEMP in this context, also referred to as an emergency operations plan, is addressed in FEMA's Comprehensive Preparedness Guide 101, “Developing and Maintaining Emergency Operations Plans,” which is publicly available at
In accordance with 10 CFR 50.12, “Specific exemptions,” the Commission may, upon application by any interested person or upon its own initiative, grant exemptions from the requirements of 10 CFR part 50 when: (1) the exemptions are authorized by law, will not present an undue risk to public health and safety, and are consistent with the common defense and security; and (2) any of the special circumstances listed in 10 CFR 50.12(a)(2) are present. These special circumstances include, among other things, that the application of the regulation in the particular circumstances would not serve the underlying purpose of the rule or is not necessary to achieve the underlying purpose of the rule.
As noted previously, the EP regulations contained in 10 CFR 50.47(b) and Appendix E to 10 CFR part 50 apply to both operating and shutdown power reactors. The NRC has consistently acknowledged that the risk of an offsite radiological release at a power reactor that has permanently ceased operations and permanently removed fuel from the reactor vessel is significantly lower, and the types of possible accidents are significantly fewer, than at an operating power reactor. However, the EP regulations do not recognize that once a power reactor permanently ceases operation, the risk of a large radiological release from credible emergency accident scenarios is significantly reduced. The reduced risk for any significant offsite radiological release is based on two factors. One factor is the elimination of accidents applicable only to an operating power reactor, resulting in fewer credible accident scenarios. The second factor is the reduced short-lived radionuclide inventory and decay heat production due to radioactive decay. Due to the permanently defueled status of the reactor, no new spent fuel will be added to the SFP and the radionuclides in the current spent fuel will continue to decay as the spent fuel ages. The irradiated fuel will produce less heat due to radioactive decay, increasing the available time to mitigate a loss of water inventory from the SFP. The NRC's NUREG/CR-6451, “A Safety and Regulatory Assessment of Generic BWR [Boiling Water Reactor] and PWR [Pressurized Water Reactor] Permanently Shutdown Nuclear Power Plants,” dated August 1997 (ADAMS Accession No. ML082260098), and the NRC's NUREG-1738, “Technical Study of Spent Fuel Pool Accident Risk at Decommissioning Nuclear Power Plants,” dated February 2001 (ADAMS Accession No. ML010430066), confirmed that for permanently shutdown and defueled power reactors that are bounded by the assumptions and conditions in the report, the risk of offsite radiological release is significantly less than for an operating power reactor.
In the past, EP exemptions similar to those requested for Oyster Creek, have been granted to permanently shutdown and defueled power reactor licensees. However, the exemptions did not relieve the licensees of all EP requirements. Rather, the exemptions allowed the licensees to modify their emergency plans commensurate with the credible site-specific risks that were consistent with a permanently shutdown and defueled status. Specifically, the NRC's approval of these prior exemptions was based on the licensee's demonstration that: (1) the radiological consequences of design-basis accidents would not exceed the limits of the U.S. Environmental Protection Agency's (EPA) early phase Protective Action Guides (PAGs) of one roentgen equivalent man (rem) at the exclusion area boundary; and (2) in the highly unlikely event of a beyond-design-basis accident resulting in a loss of all modes of heat transfer from the fuel stored in the SFP, there is sufficient time to initiate appropriate mitigating actions, and if needed, for offsite authorities to implement offsite protective actions using a CEMP approach to protect the health and safety of the public.
With respect to design-basis accidents at Oyster Creek, the licensee provided an analysis demonstrating that 12 months (365 days) following permanent cessation of power operations, the radiological consequences of the only remaining design-basis accident with potential for offsite radiological release (the fuel handling accident in the Auxiliary Building, where the SFP is located) will not exceed the limits of the EPA PAGs at the exclusion area boundary.
With respect to beyond-design-basis accidents at Oyster Creek, the licensee analyzed a drain down of the SFP water that would effectively impede any decay heat removal. The analysis demonstrates that at 12 months (365 days) after permanent cessation of power operations, there would be 10 hours after the assemblies have been uncovered until the limiting fuel assembly (for decay heat and adiabatic heatup analysis) reaches 900 degrees Celsius (°C), the temperature used to assess the potential onset of fission product release. The analysis conservatively assumed that the heat up time starts when the SFP has been completely drained, although it is likely that site personnel will start to respond to an incident when drain down starts. The analysis also does not consider the period of time from the initiating event causing loss of SFP water inventory until cooling is lost.
The NRC reviewed the licensee's justification for the requested exemptions against the criteria in 10 CFR 50.12(a) and determined, as described below, that the criteria in 10 CFR 50.12(a) will be met, and that the exemptions should be granted 365 days after Oyster Creek has permanently defueled. An assessment of the Exelon EP exemptions is described in SECY-18-0062, “Request by the Exelon Generation Company, LLC for Exemptions from Certain Emergency Planning Requirements for the Oyster Creek Nuclear Generating Station,” dated May 31, 2018 (ADAMS Accession No. ML18030B340). The Commission approved the NRC staff's recommendation to grant the exemptions in the staff requirements memorandum to SECY-18-0062, dated July 17, 2018 (ADAMS Accession No. ML18198A449). Descriptions of the specific exemptions requested by Exelon and the NRC staff's basis for granting each exemption are provided in SECY-18-0062. The NRC staff's detailed review and technical basis for the approval of the specific EP exemptions requested by Exelon, are provided in the NRC staff's safety evaluation associated with this exemption (ADAMS Accession No. ML18220A980).
The licensee has proposed exemptions from certain EP requirements in 10 CFR 50.47(b), 10 CFR 50.47(c)(2), and 10 CFR 50, Appendix E, Section IV, that would allow Exelon to revise the Oyster Creek Emergency Plan to reflect the permanently shutdown and defueled condition of the facility. As stated above, in accordance with 10 CFR 50.12, the Commission may, upon application by any interested person or upon its own initiative, grant exemptions from the requirements of 10 CFR part 50. The NRC staff has determined that granting of the licensee's proposed exemptions will not result in a violation of the Atomic Energy Act of 1954, as amended, or the NRC's regulations. Therefore, the exemptions are authorized by law.
As stated previously, Exelon provided an analysis that show that the radiological consequences of design-basis accidents will not exceed the limits of the EPA early phase PAGs at the exclusion area boundary. Therefore, formal offsite radiological emergency preparedness plans required under 10 CFR part 50 will no longer be needed for protection of the public beyond the exclusion area boundary, based on the radiological consequences of design-basis accidents still possible at Oyster Creek 365 days after the plant has permanently ceased power operations.
Although highly unlikely, there is one postulated beyond-design-basis accident that might result in significant offsite radiological releases. However, NUREG-1738 confirms that the risk of beyond-design-basis accidents is greatly reduced at permanently shutdown and defueled reactors. The NRC staff's analyses in NUREG-1738 conclude that the event sequences important to risk at permanently shutdown and defueled power reactors are limited to large earthquakes and cask drop events. For EP assessments, this is an important difference relative to operating power reactors, where typically a large number of different sequences make significant contributions to risk. As described in NUREG-1738, relaxation of offsite EP requirements in 10 CFR part 50 beyond a few months after shutdown resulted in only a small change in risk. The report further concludes that the change in risk due to relaxation of offsite EP requirements is small because the overall risk is low, and because even under current EP requirements for operating power reactors, EP was judged to have marginal impact on evacuation effectiveness for the severe earthquakes that dominate SFP risk. All other sequences including cask drops (for which offsite radiological emergency preparedness plans are expected to be more effective) are too low in likelihood to have a significant impact on risk.
Therefore, granting exemptions to eliminate the requirements of 10 CFR part 50 to maintain offsite radiological emergency preparedness plans and to reduce the scope of onsite EP activities will not present an undue risk to the public health and safety.
The requested exemptions only involve EP requirements under 10 CFR part 50 and will allow Exelon to revise the Oyster Creek Emergency Plan to reflect the permanently shutdown and defueled condition of the facility. Physical security measures at Oyster Creek are not affected by the requested EP exemptions. The discontinuation of formal offsite radiological emergency preparedness plans and the reduction in scope of the onsite EP activities at Oyster Creek will not adversely affect Exelon's ability to physically secure the site or protect special nuclear material. Therefore, the proposed exemptions are consistent with common defense and security.
Special circumstances, in accordance with 10 CFR 50.12(a)(2)(ii), are present whenever application of the regulation in the particular circumstances is not necessary to achieve the underlying purpose of the rule. The underlying purpose of 10 CFR 50.47(b), 10 CFR 50.47(c)(2), and 10 CFR part 50, Appendix E, Section IV, is to provide reasonable assurance that adequate protective measures can and will be taken in the event of a radiological emergency, to establish plume exposure and ingestion pathway emergency planning zones for nuclear power plants, and to ensure that licensees maintain effective offsite and onsite radiological emergency preparedness plans. The standards and requirements in these regulations were developed by considering the risks associated with operation of a power reactor at its licensed full-power level. These risks include the potential for a reactor accident with offsite radiological dose consequences.
As discussed previously in Section III, because Oyster Creek will be permanently shut down and defueled, there will no longer be a risk of a significant offsite radiological release from a design-basis accident exceeding EPA early phase PAG at the exclusion area boundary and the risk of a significant offsite radiological release from a beyond-design-basis accident is greatly reduced when compared to an operating power reactor. The NRC staff has confirmed the reduced risks at Oyster Creek by comparing the generic risk assumptions in the analyses in NUREG-1738 to site-specific conditions at Oyster Creek and determined that the risk values in NUREG-1738 bound the risks presented at Oyster Creek. As indicated by the results of the research conducted for NUREG-1738, and more recently for NUREG-2161, “Consequence Study of a Beyond-Design-Basis Earthquake Affecting the Spent Fuel Pool for a U.S. Mark I Boiling Water Reactor,” dated September 2014 (ADAMS Accession No. ML14255A365), while other consequences can be extensive, accidents from SFPs with significant decay time have little potential to cause offsite early fatalities, even if the formal offsite radiological EP requirements were relaxed. The licensee's analysis of a beyond-design-basis accident involving a complete loss of SFP water inventory, based on an adiabatic heatup analysis of the limiting fuel assembly for decay heat, shows that within 12 months (365 days) after permanent cessation of power operations, the time for the limiting fuel assembly to reach 900 °C is at least 10 hours after the assemblies have been uncovered assuming a loss of all cooling means.
The only analyzed beyond-design-basis accident scenario that progresses to a condition where a significant offsite release might occur, involves the highly unlikely event where the SFP drains in such a way that all modes of cooling or heat transfer are assumed to be unavailable, which is referred to as an adiabatic heatup of the spent fuel. The licensee's analysis of this beyond-design-basis accident shows that within 12 months (365 days) after permanent cessation of power operations, at least 10 hours would be available between the time that all cooling means are lost to the fuel (at which time adiabatic heatup is conservatively assumed to begin), until the fuel cladding reaches a temperature of 1652 degrees Fahrenheit (900 °C), which is the temperature associated with rapid cladding oxidation and the potential for a significant radiological release. This analysis conservatively does not include the period of time from the initiating event causing a loss of SFP water inventory until all cooling means are lost.
The NRC staff has verified Exelon's analyses and its calculations. The analyses provide reasonable assurance that in granting the requested exemptions to Exelon, there is no design-basis accident that will result in an offsite radiological release exceeding the EPA early phase PAGs at the exclusion area boundary. In the highly unlikely event of a beyond-design-basis accident affecting the SFP that results in a complete loss of heat removal via all modes of heat transfer, there will be over 10 hours available before an offsite release might occur and, therefore, at least 10 hours to initiate appropriate mitigating actions to restore a means of heat removal to the spent fuel. If a radiological release were projected to occur under this highly unlikely scenario, a minimum of 10 hours is considered sufficient time for offsite authorities to implement protective actions using a CEMP approach to protect the health and safety of the public.
Exemptions from the offsite EP requirements in 10 CFR Part 50 have previously been approved by the NRC when the site-specific analyses show that at least 10 hours is available following a loss of SFP coolant inventory accident with no air cooling (or other methods of removing decay heat) until cladding of the hottest fuel assembly reaches the rapid oxidation temperature. The NRC staff concluded in its previously granted exemptions, as it does with Exelon's requested EP exemptions, that if a minimum of 10 hours is available to initiate mitigative actions consistent with plant conditions, or if needed, for offsite authorities to implement protective actions using a CEMP approach, then formal offsite radiological emergency preparedness plans, required under 10 CFR Part 50, are not necessary at permanently shutdown and defueled facilities.
Additionally, Oyster Creek committed to maintaining SFP makeup strategies in its letters to the NRC dated March 8 and 19, 2018. The multiple strategies for providing makeup to the SFP include: using existing plant systems for inventory makeup; an internal strategy that relies on the fire protection system with redundant pumps (one diesel-driven and electric motor-driven); and onsite diesel fire truck that can take suction from the Barnegat Bay. These strategies will continue to be required as condition 2.C.(8), “Mitigation Strategy License Condition,” of renewed facility operating license DPR-16 for Oyster Creek. Considering the very low probability of beyond-design-basis accidents affecting the SFP, these diverse strategies provide multiple methods to obtain additional makeup or spray to the SFP before the onset of any postulated offsite radiological release.
For all of the reasons stated above, the NRC staff finds that the licensee's requested exemptions meet the underlying purpose of all of the standards in 10 CFR 50.47(b), and requirements in 10 CFR 50.47(c)(2) and 10 CFR Part 50, Appendix E, and satisfy the special circumstances provision in 10 CFR 50.12(a)(2)(ii) in view of the greatly reduced risk of offsite radiological consequences associated with the permanently shutdown and defueled state of the Oyster Creek facility 12 months (365 days) after permanent cessation of power operations.
The NRC staff has concluded that the exemptions being granted by this action will maintain an acceptable level of emergency preparedness at Oyster Creek and, if needed, that there is reasonable assurance that adequate offsite protective measures can and will be taken by State and local government agencies using a CEMP approach in the unlikely event of a radiological emergency at Oyster Creek. Since the underlying purposes of the rules, as exempted, would continue to be achieved, even with the elimination of the requirements under 10 CFR Part 50 to maintain formal offsite radiological emergency preparedness plans and the reduction in the scope of the onsite emergency planning activities at Oyster Creek, the special circumstances required by 10 CFR 50.12(a)(2)(ii) exist.
In accordance with 10 CFR 51.31(a), the Commission has determined that the granting of this exemption will not have a significant effect on the quality of the human environment as discussed in the NRC staff's Finding of No Significant Impact and associated Environmental Assessment published in the
Accordingly, the Commission has determined that, pursuant to 10 CFR 50.12, Exelon's request for exemptions from certain EP requirements in 10 CFR 50.47(b), 10 CFR 50.47(c)(2), and 10 CFR Part 50, Appendix E,
Dated at Rockville, Maryland, this 16th day of October 2018.
For the Nuclear Regulatory Commission.
Nuclear Regulatory Commission.
Determination of the successful completion of inspections, tests, and analyses.
The U.S. Nuclear Regulatory Commission (NRC) staff has determined that the inspections, tests, and analyses have been successfully completed, and that the specified acceptance criteria are met for the Vogtle Electric Generating Plant (VEGP), Units 3 and 4.
The determination of the successful completion of inspections, tests, and analyses for VEGP Units 3 and 4 is effective October 22, 2018.
Please refer to Docket ID NRC-2008-0252 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:
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•
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Chandu Patel, Office of New Reactors, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-3025; email:
Southern Nuclear Operating Company, Inc. (SNC), Georgia Power Company, Oglethorpe Power Corporation, MEAG Power SPVM, LLC., MEAG Power SPVJ, LLC., MEAG Power SPVP, LLC., and the City of Dalton, Georgia, (hereafter called the licensee) have submitted Inspections, Tests, Analyses, and Acceptance Criteria (ITAAC) closure notifications (ICNs) under paragraph 52.99(c)(1) of title 10 of the
The ITAAC for VEGP Unit 3 are in Appendix C of the VEGP Unit 3 combined license (ADAMS Accession No. ML14100A106). The ITAAC for VEGP Unit 4 are in Appendix C of VEGP Unit 4 combined license (ADAMS Accession No. ML14100A135).
The NRC staff has determined that the specified inspections, tests, and analyses have been successfully completed, and that the specified acceptance criteria are met. The documentation of the NRC staff's determination is in the ITAAC Closure Verification Evaluation Form (VEF) for each ITAAC. The VEF is a form that represents the NRC staff's structured process for reviewing ICNs. Each ICN presents a narrative description of how the ITAAC was completed. The NRC's ICN review process involves a determination on whether, among other things: (1) Each ICN provides sufficient information, including a summary of the methodology used to perform the ITAAC, to demonstrate that the inspections, tests, and analyses have been successfully completed; (2) each ICN provides sufficient information to demonstrate that the acceptance criteria of the ITAAC are met; and (3) any NRC inspections for the ITAAC have been completed and any ITAAC findings associated with that ITAAC have been closed.
The NRC staff's determination of the successful completion of these ITAAC is based on information available at this time and is subject to the licensee's ability to maintain the condition that the acceptance criteria are met. If the staff receives new information that suggests the staff's determination on any of these ITAAC is incorrect, then the staff will determine whether to reopen that ITAAC (including withdrawing the staff's determination on that ITAAC). The NRC staff's determination will be used to support a subsequent finding, pursuant to 10 CFR 52.103(g), at the end of construction that all acceptance criteria in the combined license are met. The ITAAC closure process is not finalized for these ITAAC until the NRC makes an affirmative finding under 10 CFR 52.103(g). Any future updates to the status of these ITAAC will be reflected on the NRC's website at
This notice fulfills the staff's obligations under 10 CFR 52.99(e)(1) to publish a notice in the
A complete list of the review status for VEGP Unit 3 ITAAC, including the submission date and ADAMS Accession Number for each ICN received, the
A complete list of the review status for VEGP Unit 4 ITAAC, including the submission date and ADAMS Accession Number for each ICN received, the ADAMS Accession Number for each VEF, and the ADAMS Accession Numbers for the inspection reports associated with these specific ITAAC, can be found on the NRC's website at
For the Nuclear Regulatory Commission.
U.S. Office of Personnel Management (OPM).
Notice.
This notice identifies Schedule A, B, and C appointing authorities applicable to a single agency that were established or revoked from May 1, 2018 to May 31, 2018.
Senior Executive Resources Services, Senior Executive Services and Performance Management, Employee Services, Julia Alford, 202-606-2246,
In accordance with 5 CFR 213.103, Schedule A, B, and C appointing authorities available for use by all agencies are codified in the Code of Federal Regulations (CFR). Schedule A, B, and C appointing authorities applicable to a single agency are not codified in the CFR, but the Office of Personnel Management (OPM) publishes a notice of agency-specific authorities established or revoked each month in the
No Schedule A Authorities to report during May 2018.
No Schedule B Authorities to report during May 2018.
The following Schedule C appointing authorities were approved during May 2018.
The following Schedule C appointing authorities were revoked during May 2018.
5 U.S.C. 3301 and 3302; E.O. 10577, 3 CFR, 1954-1958 Comp., p. 218.
U.S. Office of Personnel Management.
Pursuant to Section 19(b)(1)
The Exchange proposes non-substantive amendments to Rules 1.1, 7.31, and 7.46. 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 reorganize the terms defined in Rule 1.1, Definitions, to place them in alphabetical order. The Exchange does not propose to amend the definition of any term that is currently defined in Rule 1.1. The Exchange also proposes to adopt a definition of the term “Exchange Act” under Rule 1.1(h), which would be defined as “the Securities Exchange Act of 1934, as amended.” This definition is identical
The Exchange also proposes to amend Rules 7.31 and 7.46 to re-name “Limit Non-Routable Order” as “Non-Routable Limit Order” and “Limit Non-Displayed Order” as “Non-Displayed Limit Order.” These proposed rule changes are based on the terms used by the Exchange's affiliates, NYSE American LLC (“NYSE American”) and NYSE Arca, for the same order types.
The proposed rule change is consistent with Section 6(b) of the Securities Exchange Act of 1934 (the “Act”),
The Exchange believes that alphabetizing the defined terms under Rule 1.1 would remove impediments to, and perfect the mechanism of, a free and open market and a national market system because it add clarity to the Exchange's rules and make the defined terms easier to navigate. The Exchange does not propose to amend the definition of any term that is currently defined in Rule 1.1. In addition, the proposed definition of the term “Exchange Act” under Rule 1.1(h), is identical to the same definition in the rules of the Exchange's affiliate, NYSE Arca.
The Exchange also believes that renaming “Limit Non-Displayed Order” as “Non-Displayed Limit Order” and “Limit Non-Routable Order” as “Non-Routable Limit Order” would remove impediments to and perfect the mechanism of a free and open market and a national market system because the proposed changes are designed to promote clarity and consistency in Exchange rules by moving the modifier describing the function of the order type before the term “Limit Order.” The Exchange does not propose any changes to the operation of either order type. These proposed rule changes are also based on the terms used by the Exchange's affiliates, NYSE American and NYSE Arca, for the same order types,
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 proposed rule change will not have any impact on competition because it simply alphabetize definitions and renames two order types and does not make any changes to the operation of those order types or to alter any existing definition. In addition, the proposed definition of “Exchange Act” will not have a competitive impact because the new definition is intended to simply add clarity to the Exchange's rules and is identical to the same definition in the rules of the Exchange's affiliate, NYSE Arca.
No written comments were solicited or received with respect to the proposed rule change.
The Exchange has filed the proposed rule change pursuant to Section 19(b)(3)(A)(iii) of the Act
At any time within 60 days of the filing of such proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings under Section 19(b)(2)(B)
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Brent J. Fields, Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
On October 10, 2018, Hurricane Michael made landfall on the Florida Panhandle. The storm and subsequent flooding has displaced individuals and businesses and disrupted communications and transportation across the affected region. We are issuing this Order to address the needs of companies and individuals with obligations under the federal securities laws who have been directly or indirectly affected by Hurricane Michael and its aftermath.
Section 15B(a)(4) of the Securities Exchange Act of 1934 (the “Exchange Act”) provides that the Securities and Exchange Commission (the “Commission”), by rule or order, upon its own motion or upon application, may conditionally or unconditionally exempt any broker, dealer, municipal securities dealer or municipal advisor, or class of brokers, dealers, municipal securities dealers, or municipal advisors from any provision of Section 15B or the rules or regulations thereunder, if the Commission finds that such exemption is consistent with the public interest, the protection of investors and the purposes of Section 15B.
Section 36 of the Exchange Act authorizes the Commission, by rule, regulation or order, to exempt, either conditionally or unconditionally, any person, security or transaction, or any class or classes of persons, securities or transactions, from any provision or provisions of the Exchange Act or any rule or regulation thereunder, to the extent that such exemption is necessary or appropriate in the public interest, and is consistent with the protection of investors.
Section 17A(c)(1) of the Exchange Act provides that the appropriate regulatory agency, by rule or by order, upon its own motion or upon application, may conditionally or unconditionally exempt any person or security or class of persons or securities from any provision of Section 17A or any rule or regulation prescribed under Section 17A, if the appropriate regulatory agency
Section 6(c) of the Investment Company Act of 1940 (the “Company Act”) provides that the Commission may conditionally or unconditionally exempt any person, security or transaction, or any class or classes of persons, securities or transactions, from any provision or provisions of the Company Act, or any rule or regulation thereunder, if and to the extent that such exemption is necessary or appropriate in the public interest and consistent with the protection of investors and the purposes fairly intended by the policy and provisions of the Company Act. Section 38(a) of the Company Act provides that the Commission may make, issue, amend and rescind such rules and regulations and such orders as are necessary or appropriate to the exercise of the powers conferred upon the Commission under the Company Act.
The necessity for prompt action of the Commission does not permit prior notice of the Commission's action.
The time period for the relief specified in Sections II and VI of this Order is as follows:
• With respect to those persons or entities affected by Hurricane Michael, for the period from and including October 10, 2018 to November 21, 2018, all reports, schedules or forms must be filed on or before November 23, 2018.
The lack of communications, transportation, electricity, facilities and available staff and professional advisors as a result of Hurricane Michael could hamper the efforts of public companies and other persons with filing obligations to meet their filing deadlines. At the same time, investors have an interest in the timely availability of required information about these companies and the activities of persons required to file schedules and reports with respect to these companies. While the Commission believes that the relief from filing requirements provided by the exemption below is necessary and appropriate in the public interest and consistent with the protection of investors, we remind public companies and other persons who are the subjects of this Order to continue to evaluate their obligations to make materially accurate and complete disclosures in accordance with the anti-fraud provisions of the federal securities laws.
Accordingly,
(a) The registrant or person other than a registrant is not able to meet a filing deadline due to Hurricane Michael and its aftermath;
(b) The registrant or person other than a registrant files with the Commission any report, schedule or form required to be filed during the applicable period of relief on or before the applicable deadline set forth in Section I; and
(c) In any such report, schedule or form filed pursuant to this Order, the registrant or person other than a registrant must disclose that it is relying on this Order and state the reasons why, in good faith, it could not file such report, schedule or form on a timely basis.
The conditions in the areas affected by Hurricane Michael, including displacement of thousands of individuals and the destruction of property, have prevented and will continue to prevent the delivery of mail to the affected areas. In light of these conditions, we believe that relief is warranted for those seeking to comply with our rules imposing requirements to furnish materials to security holders when mail delivery is not possible and that the following exemption is necessary and appropriate in the public interest and consistent with the protection of investors.
Accordingly,
(a) The registrant's security holder has a mailing address located within a zip code where, as a result of Hurricane Michael, the registrant's common carrier has suspended delivery service of the type or class customarily used by the registrant;
(b) The registrant or other person making a solicitation has followed normal procedure when furnishing the Soliciting Materials to the security holder in order to ensure that the Soliciting Materials preceded or accompanied the proxy, as required by the rules applicable to the particular form of Soliciting Materials, or, in the case of Information Materials, the registrant has followed normal procedure when furnishing the Information Materials to the security holder in accordance with the rules applicable to Information Materials; and
(c) If requested by the security holder, the registrant or other person provides the Soliciting Materials or Information Materials by a means reasonably designed to furnish the Soliciting Materials or Information Materials to the security holder.
Any registrant or other person in need of additional assistance related to deadlines, delivery obligations or their public filings, should contact the Division of Corporation Finance at (202) 551-3500 or at
For reasons similar to those cited in Section III, we believe that relief is warranted for the transmittal by registered management investment companies and registered unit investment trusts (collectively, “registered investment companies”) of annual and semi-annual reports to investors and that the following exemption is necessary and appropriate in the public interest and consistent with the protection of investors.
Accordingly,
For the period from and including October 10, 2018 to November 21, 2018, a registered unit investment trust is exempt from the requirements of Section 30(e) of the Company Act and Rule 30e-2 thereunder to transmit annual and semi-annual reports to unitholders affected by Hurricane Michael,
(a) The affected investor's mailing address for transmittal as listed in the records of the registered investment company has a zip code for which the registered investment company's common carrier has suspended mail service, as a result of Hurricane Michael, of the type or class customarily used by the registered investment company for transmittal of reports; and
(b) The registered investment company or other person promptly transmits the reports to affected investors: Either (a) if requested by the investor; or (b) at the earlier of (i) November 23, 2018 or (ii) the resumption of the applicable mail service.
Registered investment companies who are unable to meet a deadline as extended by this relief, or in need of additional assistance regarding issues under the Company Act, should contact the Division of Investment Management, Office of Chief Counsel, at (202) 551-6825 or
Registered investment advisers in need of additional assistance regarding issues under the Investment Advisers Act of 1940 should contact the Division of Investment Management, Investment Adviser Regulation Office, at (202) 551-6999 or
Exchange Act Section 17A and Section 17(f), as well as the rules promulgated under Sections 17A and 17(f), contain requirements for registered transfer agents relating to, among other things, processing securities transfers, safekeeping of investor and issuer funds and securities and maintaining records of investor ownership. Following the events of Hurricane Michael, registered transfer agents located in the affected regions may have difficulty complying with some or all of their obligations as registered transfer agents. In addition, registered transfer agents located outside the affected regions may be unable to conduct business with entities or security holders inside the regions, thereby making it difficult to process securities transactions and corporate actions in conformance with Section 17A, Section 17(f) and the rules thereunder.
While the national clearance and settlement system continues to operate well in light of these emergencies, the Commission recognizes that the need to effect securities transfers and payments to and from security holders in the affected regions may present compliance issues for affected transfer agents. Therefore, the Commission is using its authority under Section 17A and Section 36 of the Exchange Act to provide temporary relief from certain regulatory provisions. This Order temporarily exempts transfer agents
Accordingly,
(a) A registered transfer agent relying on this Order must notify the Commission in writing by November 21, 2018 of the following:
(1) The transfer agent is relying on this Order;
(2) A statement of the reasons why, in good faith, the transfer agent is unable to comply with Section 17A and Section 17(f) of the Exchange Act and the rules promulgated thereunder, as applicable;
(3) If the transfer agent knows or believes that the books and records it is required to maintain pursuant to Section 17A and the rules thereunder were lost, destroyed or materially damaged, information, to the extent reasonably available, as to the type of books and records that were maintained, the names of the issuers for whom such books and records were maintained, the extent of the loss of, or damage to, such books and records and the steps taken to ameliorate any such loss or damage; and
(4) If the transfer agent knows or believes that funds or securities belonging to either issuers or security holders and within its possession were, for any reason, lost, destroyed, stolen or unaccounted for, information, to the extent reasonably available, regarding the dollar amount of any such funds and the number of such securities and the steps taken to ameliorate any such loss; and
(b) Transfer agents that have custody or possession of any security holder or issuer funds or securities shall use all reasonable means available to ensure that all such securities are held in safekeeping and are handled, in light of all facts and circumstances, in a manner reasonably free from risk of theft, loss or destruction and that all funds are protected against misuse. To the extent possible, all security holder or issuer funds that remain in the custody of the transfer agent shall be maintained in a separate bank account held for the exclusive benefit of security holders until such funds are properly remitted.
The notification required under (a) above shall be sent to:
The Commission encourages registered transfer agents and the issuers for whom they act to inform affected security holders whom they should contact concerning their accounts, their access to funds or securities and other shareholder concerns. If feasible, issuers and their transfer agents should place a notice on their websites or providing toll free numbers to respond to inquiries.
Transfer agents who are unable to meet a deadline as extended by this relief, or in need of additional assistance, should contact the Division of Trading and Markets at (202) 551-5777 or
Section 15B of the Exchange Act and Rule 15Ba1-5(a)(1) thereunder requires each registered municipal advisor to file with the Commission an annual update to its Form MA. For reasons similar to those cited in Section II, the Commission believes that relief is warranted for the filing with the Commission of annual updates to Form MA by registered municipal advisors and that such relief is consistent with the public interest, the protection of investors and the purposes of Section 15B of the Exchange Act.
Accordingly,
(a) The registered municipal advisor is not able to fulfill its obligation to file an annual update to the registered municipal advisor's Form MA within 90 days of the end of the registered municipal advisor's fiscal year due to Hurricane Michael;
(b) The registered municipal advisor files with the Commission its annual update to Form MA required to be filed during the applicable period of relief on or before the applicable deadline set forth in Section I; and
(c) In any such annual update to its Form MA filing, the registered municipal advisor must disclose that it is relying on this Order and state the reasons why, in good faith, it could not file such annual update to Form MA on a timely basis.
Registered municipal advisors who are unable to meet a deadline as extended by this relief or in need of additional assistance, should contact the Office of Municipal Securities at (202) 551-5680 or
The conditions in the areas affected by Hurricane Michael, including displacement of individuals, the destruction of property and loss or destruction of corporate records, may require extraordinary efforts to reconstruct lost or destroyed accounting records. The Commission understands that in these particularly challenging situations an audit client may look to its auditor for assistance in reconstruction of its accounting records because of the auditor's knowledge of the client's financial systems and records. Under Section 10A(g)(1) of the Exchange Act and Rule 2-01(c)(4)(i) of Regulation S-X, auditors are prohibited from providing bookkeeping or other services relating to the accounting records of the audit client, and in Rule 2-01(c)(4)(i) of Regulation S-X, these prohibited services are described as including “maintaining or preparing the audit client's accounting records” or “preparing or originating source data underlying the audit client's financial statements.” In light of the conditions in areas affected by Hurricane Michael, however, we believe that limited relief from these prohibitions is warranted for those registrants and other persons that are required to comply with the independence requirements of the federal securities laws and the Commission's rules and regulations thereunder and that are affected by those conditions. The Commission finds the following exemption to be necessary and appropriate in the public interest and consistent with the protection of investors.
Accordingly,
(a) Services provided by the auditor are limited to reconstruction of previously existing accounting records that were lost or destroyed as a result of Hurricane Michael and such services cease as soon as the audit client's lost or destroyed records are reconstructed, its financial systems are fully operational and the client can effect an orderly and efficient transition to management or other service provider; and
(b) Services provided by the auditor to its audit client pursuant to this Order are subject to pre-approval by the audit client's audit committee as required by Rule 2-01(c)(7) of Regulation S-X.
Auditors or audit clients who are in need of additional assistance or have other questions relating to auditor independence, should contact the Office of the Chief Accountant at (202) 551-5300 or
By the Commission.
Securities and Exchange Commission (“Commission”).
Notice.
Notice of application for an order under sections 17(d) and 57(i) of the Investment Company Act of 1940 (the “Act”) and rule 17d-1 under the Act to permit certain joint transactions otherwise prohibited by sections 17(d) and 57(a)(4) of the Act and rule 17d-1 under the Act.
Applicants have agreed to file an amendment during the notice period, the substance of which is reflected in this notice.
Secretary, U.S. Securities and Exchange Commission, 100 F St, NE, Washington, DC 20549-1090. Applicants: Leon Volchyok, Esq., 345 Park Avenue, New York, New York 10154.
Asen Parachkevov, Senior Counsel, or David J. Marcinkus, Branch Chief, at (202) 551-6821 (Chief Counsel's Office, Division of Investment Management).
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. Each BREI Regulated Fund is a Delaware statutory trust and is structured as an externally managed, non-diversified, closed-end management investment company. Each BREI Regulated Fund's investment objective is to seek long-term total return, with an emphasis on current income, by primarily investing in a broad range of real estate-related deb investments. BREIF and BREIF II are “feeder” funds in a “master-feeder” structure and pursues their respective investment objective by investing substantially all of their assets in the BREI Master Fund. Each BREI Regulated Fund has a five-member Board, of which four members are Non-Interested Trustees.
“Non-Interested Trustees” means the Non-Interested Trustees of the BREI Regulated Funds and any other Regulated Fund who are not “interested persons” within the meaning of section 2(a)(19) of the Act.
2. Each Adviser
The term “Primary Adviser” means any future investment adviser that (i) controls, is controlled by or is under common control with an Adviser, (ii) is registered as an investment adviser under the Advisers Act, and (iii) is not an Adviser. For the avoidance of doubt, a Primary Adviser will not be treated as an Adviser under the requested Order, but will be subject to conditions 2(c)(iv) and 13 of the requested Order. A Primary Adviser will not rely on the requested Order with respect to any investment vehicles it manages other than to the extent those vehicles are sub-advised by an Adviser.
3. The Blackstone RE Advisers operate as a self-contained advisory business within Blackstone's real estate.
4. Applicants seek an order to permit one or more Regulated Funds
Section 2(a)(48) of the Act defines a BDC to be any closed-end investment company that operates for the purpose of making investments in securities described in sections 55(a)(1) through 55(a)(3) of the Act and makes available significant managerial assistance with respect to the issuers of such securities.
“Future Affiliated Fund” means an entity (i)(A) whose investment adviser is an Adviser or (B) whose investment adviser is a Primary Adviser and whose sub-adviser is an Adviser (a “Sub-Advised Affiliated Fund”), and (ii) that either (A) would be an investment company but for an exemption in section 3(c)(1), 3(c)(5)(C) or 3(c)(7) of the Act or (B) relies on the rule 3a-7 exemption thereunder from investment company status, and (iii) that intends to participate in the Co-Investment Program.
“Affiliated Proprietary Account” means any account of an Adviser or its affiliates or any company that is an indirect, wholly- or majority-owned subsidiary of an Adviser or its affiliates, which, from time to time, may hold various financial assets in a principal capacity. For the avoidance of doubt, neither the Regulated Funds, the Existing Affiliated Funds nor any Future Affiliated Funds shall be deemed to be Affiliated Proprietary Accounts for purposes of the requested Order.
5. For purposes of the requested Order, “Co-Investment Transaction” means any transaction in which one or more Regulated Funds (or one or more Wholly-Owned Investment Subsidiaries, as defined below) participates together with one or more other Regulated Funds (or one or more Wholly-Owned Investment Subsidiaries, as defined below) and/or one or more Affiliated Investors in reliance on the requested Order. “Potential Co-Investment Transaction” means any investment opportunity in which a Regulated Fund (or its Wholly-Owned Investment Subsidiary, as defined below) could not participate together with one or more Affiliated Investors and/or one or more other Regulated Funds without obtaining and relying on the requested Order.
6. Applicants state that a Regulated Fund may, from time to time, form a special purpose subsidiary (a “Wholly-Owned Investment Subsidiary”).
The term “SBIC Subsidiary” means a Wholly-Owned Investment Subsidiary that is licensed by the Small Business Administration (the “SBA”) to operate under the Small Business Investment Act of 1958, as amended, (the “SBA Act”) as a small business investment company (a “SBIC”).
7. When considering Potential Co-Investment Transactions for any Regulated Fund, an Adviser will consider only the Objectives and Strategies,
8. With respect to participation in a Potential Co-Investment Transaction by a Regulated Fund, the application Adviser will present each Potential Co-
9. Applicants state that the majority of the Blackstone RE Advisers' employees work on matters for Close Affiliates
10. Applicants submit that, in the event that a Potential Co-Investment Transaction would be within the investment objectives and strategies of the Sub-Advised Affiliated Fund, the respective Adviser shall have the primary responsibility for the investment, including making the initial investment recommendation, and day-to-day monitoring of the investment. Applicants further note that the Adviser will be responsible for complying with the conditions of the requested Order. Applicants state that if the Adviser and Primary Adviser agree that the Sub-Advised Affiliated Fund should invest in the Potential Co-Investment Transaction and at what size of investment, then the Adviser would, consistent with the conditions of the requested Order, determine an allocation for the Regulated Funds and Affiliated Investors, including such Sub-Advised Affiliated Fund.
11. Applicants acknowledge that some of the Affiliated Investors may not be funds advised by an Adviser because they are Affiliated Proprietary Accounts. Applicants do not believe the participation of these Affiliated Proprietary Accounts in Co-Investment Transactions should raise issues under the conditions of the requested Order because allocation policies and procedures of the account owners provide that investment opportunities are offered to client accounts before they are offered to Affiliated Proprietary Accounts.
12. Under condition 14, if an Adviser or its principals, or any person controlling, controlled by, or under common control with the Adviser or its principals, and any Affiliated Investor (collectively, the “Holders”) own in the aggregate more than 25 percent of the outstanding voting shares of a Regulated Fund (“Shares”), then the Holders will vote such Shares as directed by an independent third party when voting on (1) the election of directors; (2) the removal of one or more directors; or (3) all other matters under either the Act or applicable state law affecting the Board's composition, size or manner of election.
13. No Non-Interested Trustee of a Regulated Fund will have a financial interest in any Co-Investment Transaction, other than indirectly through share ownership in one of the Regulated Funds.
1. Section 57(a)(4) of the Act prohibits certain affiliated persons of a BDC from participating in joint transactions with the BDC or a company controlled by a BDC in contravention of rules as prescribed by the Commission. Under section 57(b)(2) of the Act, any person who is directly or indirectly controlling, controlled by, or under common control with a BDC is subject to section 57(a)(4) of the Act. Section 57(i) of the Act provides that, until the Commission prescribes rules under section 57(a)(4) of the Act, the Commission's rules under section 17(d) of the Act applicable to registered closed-end investment companies will be deemed to apply to transactions subject to section 57(a)(4) of the Act. Because the Commission has not adopted any rules under section 57(a)(4) of the Act, rule 17d-1 thereunder applies.
2. Section 17(d) of the Act and rule 17d-1 under the Act prohibit affiliated persons of a registered investment company from participating in joint transactions with the company unless the Commission has granted an order permitting such transactions. In passing upon applications under rule 17d-1, the Commission considers whether the company's participation in the joint transaction is consistent with the provisions, policies, and purposes of the Act and the extent to which such participation is on a basis different from or less advantageous than that of other participants.
3. Applicants state that certain transactions effected as part of the Co-Investment Program may be prohibited by sections 17(d) and 57(a)(4) of the Act and rule 17d-1 thereunder without a prior exemptive order of the Commission to the extent that the Affiliated Investors fall within the category of persons described by section 17(d) or section 57(b) of the Act, as modified by rule 57b-1 thereunder with respect to a Regulated Fund. Applicants believe that the proposed terms and conditions will ensure would ensure that the conflicts of interest that section 17(d) and section 57(a)(4) of the Act were designed to prevent would be addressed and the standards for an order under rule 17d-1 under the Act are met.
Applicants agree that any Order granting the requested relief shall be subject to the following conditions:
1. (a) Each Adviser will establish, maintain and implement policies and procedures reasonably designed to ensure that each Adviser is promptly notified, for each Regulated Fund the Adviser manages, of all Potential Co-Investment Transactions
(b) When an Adviser to a Regulated Fund is notified of a Potential Co-Investment Transaction under condition 1(a), such Adviser will make an independent determination of the appropriateness of the investment for the Regulated Fund in light of the Regulated Fund's then-current circumstances.
2. (a) If the Adviser deems a Regulated Fund's participation in any Potential Co-Investment Transaction to be appropriate for the Regulated Fund, it will then determine an appropriate level of investment for the Regulated Fund.
(b) If the aggregate amount recommended by the applicable Adviser to be invested by the applicable Regulated Fund in the Potential Co-Investment Transaction, together with the amount proposed to be invested by the other participating Regulated Funds and Affiliated Investors, collectively, in the same transaction, exceeds the amount of the investment opportunity, then the investment opportunity will be allocated among them pro rata based on each participant's Available Capital up
(c) After making the determinations required in conditions 1 and 2(a), the applicable Adviser will distribute written information concerning the Potential Co-Investment Transaction (including the amount proposed to be invested by each participating Regulated Fund and Affiliated Investor) to the Eligible Trustees of each participating Regulated Fund for their consideration. A Regulated Fund will co-invest with one or more other Regulated Funds and/or one or more Affiliated Investors only if, prior to the Regulated Fund's participation in the Potential Co-Investment Transaction, a Required Majority concludes that:
(i) the terms of the Potential Co-Investment Transaction, including the consideration to be paid, are reasonable and fair to the Regulated Fund and its shareholders and do not involve overreaching in respect of the Regulated Fund or its shareholders on the part of any person concerned;
(ii) the Potential Co-Investment Transaction is consistent with:
(A) the interests of the shareholders of the Regulated Fund; and
(B) the Regulated Fund's then-current Objectives and Strategies;
(iii) the investment by any other Regulated Funds or Affiliated Investors would not disadvantage the Regulated Fund, and participation by the Regulated Fund would not be on a basis different from or less advantageous than that of other Regulated Funds or Affiliated Investors; provided that, if any other Regulated Fund or Affiliated Investor, but not the Regulated Fund itself, gains the right to nominate a director for election to a portfolio company's board of directors or the right to have a board observer or any similar right to participate in the governance or management of the portfolio company, such event shall not be interpreted to prohibit the Required Majority from reaching the conclusions required by this condition (2)(c)(iii), if:
(A) the Eligible Trustees will have the right to ratify the selection of such director or board observer, if any;
(B) the applicable Adviser agrees to, and does, provide periodic reports to the Regulated Fund's Board with respect to the actions of such director or the information received by such board observer or obtained through the exercise of any similar right to participate in the governance or management of the portfolio company; and
(C) any fees or other compensation that any Affiliated Investor or any Regulated Fund or any affiliated person of any Affiliated Investor or any Regulated Fund receives in connection with the right of an Affiliated Investor or a Regulated Fund to nominate a director or appoint a board observer or otherwise to participate in the governance or management of the portfolio company will be shared proportionately among the participating Affiliated Investors (who each may, in turn, share its portion with its affiliated persons), and the participating Regulated Funds in accordance with the amount of each party's investment; and
(iv) the proposed investment by the Regulated Fund will not benefit the Advisers, the Affiliated Investors, the other Regulated Funds or any Primary Adviser or any affiliated person of any of them (other than the parties to the Co-Investment Transaction), except
(A) to the extent permitted by condition 13;
(B) to the extent permitted by section 17(e) or 57(k) of the Act, as applicable;
(C) indirectly, as a result of an interest in the securities issued by one of the parties to the Co-Investment Transaction; or
(D) in the case of fees or other compensation described in condition 2(c)(iii)(C).
3. Each Regulated Fund has the right to decline to participate in any Potential Co-Investment Transaction or to invest less than the amount proposed.
4. The applicable Adviser will present to the Board of each Regulated Fund, on a quarterly basis, a record of all investments in Potential Co-Investment Transactions made by any of the other Regulated Funds or Affiliated Investors during the preceding quarter that fell within the Regulated Fund's then-current Objectives and Strategies and Board Established Criteria that were not made available to the Regulated Fund, and an explanation of why the investment opportunities were not offered to the Regulated Fund. All information presented to the Board pursuant to this condition will be kept for the life of the Regulated Fund and at least two years thereafter, and will be subject to examination by the Commission and its staff.
5. Except for Follow-On Investments made in accordance with Condition 8,
6. A Regulated Fund will not participate in any Potential Co-Investment Transaction unless the terms, conditions, price, class of securities to be purchased, settlement date, and registration rights will be the same for each participating Regulated Fund and Affiliated Investor. The grant to an Affiliated Investor or another Regulated Fund, but not the Regulated Fund, of the right to nominate a director for election to a portfolio company's board of directors, the right to have an observer on the board of directors or similar rights to participate in the governance or management of the portfolio company will not be interpreted so as to violate this
7. (a) If any Affiliated Investor or any Regulated Fund elects to sell, exchange or otherwise dispose of an interest in a security that was acquired in a Co-Investment Transaction, the applicable Adviser will
(i) notify each Regulated Fund that participated in the Co-Investment Transaction of the proposed disposition at the earliest practical time; and
(ii) formulate a recommendation as to participation by each Regulated Fund in the disposition.
(b) Each Regulated Fund will have the right to participate in such disposition on a proportionate basis, at the same price and on the same terms and conditions as those applicable to the participating Affiliated Investors and Regulated Funds.
(c) A Regulated Fund may participate in such disposition without obtaining prior approval of the Required Majority if: (i) the proposed participation of each Regulated Fund and each Affiliated Investor in such disposition is proportionate to its outstanding investments in the issuer immediately preceding the disposition; (ii) the Board of the Regulated Fund has approved as being in the best interests of the Regulated Fund the ability to participate in such dispositions on a pro rata basis (as described in greater detail in the application); and (iii) the Board of the Regulated Fund is provided on a quarterly basis with a list of all dispositions made in accordance with this condition. In all other cases, the Adviser will provide its written recommendation as to the Regulated Fund's participation to the Eligible Trustees, and the Regulated Fund will participate in such disposition solely to the extent that a Required Majority determines that it is in the Regulated Fund's best interests.
(d) Each Affiliated Investor and each Regulated Fund will bear its own expenses in connection with any such disposition.
8. (a) If any Affiliated Investor or any Regulated Fund desires to make a Follow-On Investment in a portfolio company whose securities were acquired in a Co-Investment Transaction, the applicable Advisers will:
(i) notify each Regulated Fund that participated in the Co-Investment Transaction of the proposed transaction at the earliest practicable time; and
(ii) formulate a recommendation as to the proposed participation, including the amount of the proposed Follow-On Investment, by each Regulated Fund.
(b) A Regulated Fund may participate in such Follow-On Investment without obtaining prior approval of the Required Majority if: (i) the proposed participation of each Regulated Fund and each Affiliated Investor in such investment is proportionate to its outstanding investments in the issuer immediately preceding the Follow-On Investment; and (ii) the Board of the Regulated Fund has approved as being in the best interests of the Regulated Fund the ability to participate in Follow-On Investments on a pro rata basis (as described in greater detail in the application). In all other cases, the Adviser will provide its written recommendation as to the Regulated Fund's participation to the Eligible Trustees, and the Regulated Fund will participate in such Follow-On Investment solely to the extent that a Required Majority determines that it is in the Regulated Fund's best interests.
(c) If, with respect to any Follow-On Investment:
(i) the amount of the opportunity is not based on the Regulated Funds' and the Affiliated Investors' outstanding investments immediately preceding the Follow-On Investment; and
(ii) the aggregate amount recommended by the applicable Adviser to be invested by the applicable Regulated Fund in the Follow-On Investment, together with the amount proposed to be invested by the other participating Regulated Funds and Affiliated Investors, collectively, in the same transaction, exceeds the amount of the investment opportunity; then the amount invested by each such party will be allocated among them pro rata based on each party's Available Capital, up to the amount proposed to be invested by each.
(d) The acquisition of Follow-On Investments as permitted by this condition will be considered a Co-Investment Transaction for all purposes and subject to the other conditions set forth in the application.
9. The Non-Interested Trustees of each Regulated Fund will be provided quarterly for review all information concerning Potential Co-Investment Transactions that fell within the Regulated Fund's then-current Objectives and Strategies and Board-Established Criteria, including investments in Potential Co-Investment Transactions made by other Regulated Funds or Affiliated Investors that the Regulated Fund considered but declined to participate in, and concerning Co-Investment Transactions in which the Regulated Fund participated, so that the Non-Interested Trustees may determine whether all Potential Co-Investment Transactions and Co-Investment Transactions during the preceding quarter, including those Potential Co-Investment Transactions which the Regulated Fund considered but declined to participate in, comply with the conditions of the Order. In addition, the Non-Interested Trustees will consider at least annually: (a) the continued appropriateness for the Regulated Fund of participating in new and existing Co-Investment Transactions, and (b) the continued appropriateness of any Board-Established Criteria.
10. Each Regulated Fund will maintain the records required by section 57(f)(3) of the Act as if each of the Regulated Funds were a BDC and each of the investments permitted under these conditions were approved by the Required Majority under section 57(f) of the Act.
11. No Non-Interested Trustee of a Regulated Fund will also be a director, general partner, managing member or principal, or otherwise an “affiliated person” (as defined in the Act) of any of the Affiliated Investors.
12. The expenses, if any, associated with acquiring, holding or disposing of any securities acquired in a Co-Investment Transaction (including, without limitation, the expenses of the distribution of any such securities registered for sale under the 1933 Act) will, to the extent not payable by the Advisers under their respective investment advisory agreements with Affiliated Investors and the Regulated Funds, be shared by the Regulated Funds and the Affiliated Investors in proportion to the relative amounts of the securities held or to be acquired or disposed of, as the case may be.
13. Any transaction fee
14. If the Holders own in the aggregate more than 25% of the Shares, then the Holders will vote such Shares as directed by an independent third party when voting on (1) the election of trustees; (2) the removal of one or more trustees; or (3) all other matters under either the Act or applicable state law affecting the Board's composition, size or manner of election.
15. Each Regulated Fund's chief compliance officer, as defined in rule 38a-1(a)(4) under the Act, will prepare an annual report for its Board each year that evaluates (and documents the basis of that evaluation) the Regulated Fund's compliance with the terms and conditions of the application and the procedures established to achieve such compliance.
16. The Affiliated Proprietary Accounts will not be permitted to invest in a Potential Co-Investment Transaction except to the extent the aggregate demand from the Regulated Funds and the other Affiliated Investors is less than the total investment opportunity.
For the Commission, by the Division of Investment Management, under delegated authority.
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) index-based series of certain open-end management investment companies (“Funds”) to issue shares redeemable in large aggregations (“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: Robert Tull, ProcureAM, LLC, 16 Firebush Road, Levittown, PA 19056.
Deepak T. Pai, Senior Counsel, at (202) 551-6876, 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 index exchange traded funds (“ETFs”).
2. Each Fund will hold investment positions selected to correspond closely to the performance of an Underlying Index. In the case of Self-Indexing Funds, 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 Trust or a Fund, of the Adviser, of any sub-adviser to or promoter of a Fund, or of the Distributor will compile, create, sponsor or maintain the Underlying Index.
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.
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) secondary market trading in shares does not involve a Fund as a party and will not result in dilution of an investment in shares, and (b) to the extent different prices exist during a given trading day, or from day to day, such variances occur as a result of third-party market forces, such as supply and demand. Therefore, applicants assert that secondary market transactions in shares will not lead to discrimination or preferential treatment among purchasers. Finally, applicants represent that share market prices will be disciplined by arbitrage opportunities, which should prevent shares from trading at a material discount or premium from NAV.
6. With respect to Funds that effect creations and redemptions of Creation Units in kind and that are based on certain Underlying Indexes that include foreign securities, 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 persons that are Affiliated Persons, or Second Tier Affiliates, 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 investment positions 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.
On August 16, 2018, the Cboe Exchange, Inc. (the “Exchange” or “Cboe”) filed with the Securities and Exchange Commission (the “Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (the “Act”)
Cboe Rule 6.49 generally requires a Trading Permit Holder (“TPH”) to effect transactions in listed options on an exchange.
With respect to off-floor transfers, Cboe Rule 6.49A(a) currently sets forth specific events under which off-floor transfers are permitted. The Exchange proposes to delineate several additional events and add them to the list of permitted off-floor transfers in proposed Rule 6.49A.
In addition, proposed Rule 6.49A(b) codifies prior Exchange guidance regarding certain restrictions on permissible off-floor transfers related to the netting of open positions and to margin and haircut treatment.
Further, proposed Rule 6.49A(d) will require a TPH and its Clearing Trading Permit Holder (to the extent the TPH is not self-clearing) to submit written notice to the Exchange prior to effecting an off-floor transfer from or to the account of a TPH(s).
In addition, the Exchange is clarifying and updating Proposed Rule 6.49A(f), which allows the Exchange to grant an exemption from Rule 6.49(a) in cases where allowing an off-floor transfer would be necessary or appropriate for the maintenance of a fair and orderly market and the protection of investors and is in the public interest.
Finally, the Exchange is adding new proposed Rule 6.49A(g) to state that the off-floor position transfer process described in the Rule is “intended to facilitate non-routine, non-recurring movements of positions” and is “not to be used repeatedly or routinely in circumvention of the normal auction market process.”
After careful review, the Commission finds that the proposed rule change is consistent with the requirements of the Act,
The proposed rule change is designed to remove impediments to and perfect the mechanism of a free and open market and a national market system by providing a mechanism to permit off-floor position transfers in specified, limited, and narrowly-tailored circumstances. Thus, Rule 6.49A makes clear that off-floor positions transfers are not to be used repeatedly or routinely in circumvention of the normal auction market process.
The Commission further notes that the proposal adds transparency to the off-floor transfer process by codifying certain long-standing Cboe guidance
With respect to the elimination of the on-floor transfer package procedure, the Commission notes that TPHs will continue to be able to transact on the Exchange using the regular auction market process.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Securities and Exchange Commission.
Notice of telephonic meeting of Securities and Exchange Commission Dodd-Frank Investor Advisory Committee.
The Securities and Exchange Commission Investor Advisory Committee, established pursuant to Section 911 of the Dodd-Frank Wall Street Reform and Consumer Protection Act of 2010, is providing notice that it will hold a telephonic public meeting. The public is invited to submit written statements to the Committee.
The meeting will be held on Wednesday, November 7, 2018 from 2:00 p.m. until 3:30 p.m. (ET) and will be open to the public
Written statements may be submitted by any of the following methods:
Use the Commission's internet submission form (
Send an email message to
Send paper statements to Brent J. Fields, Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
Statements also will be available for website viewing and printing in the Commission's Public Reference Room, 100 F Street NE, Room 1503, Washington, DC 20549, on official business days between the hours of 10:00 a.m. and 3:00 p.m. All statements received will be posted without change. Persons submitting comments are cautioned that we do not redact or edit personal identifying information from comment submissions. You should submit only information that you wish to make available publicly.
Marc Oorloff Sharma, Chief Counsel, Office of the Investor Advocate, at (202) 551-3302, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549.
The meeting will be open to the public
The agenda for the meeting includes: Welcome remarks; a discussion of the Commission's Proposed Regulation Best Interest and Proposed Form CRS Relationship Summary (which may include a recommendation of the Investor as Purchaser subcommittee).
On August 24, 2018, Cboe Exchange, Inc. (“Exchange”) filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
Exchange Rule 6.2, Interpretation and Policy .01 sets forth the modified Hybrid Opening System (“HOSS”) procedure for the option series used to calculate the exercise or final settlement value for expiring volatility index derivatives.
The Exchange believes that, in the past, some market participants that have submitted strategy orders prior to the strategy order cut-off time
The proposal revises the definition of strategy order to provide that individual orders (considered collectively) that a market participant submits for participation in the modified opening procedure on exercise settlement value determination days generally are considered to be a strategy order if they: (1) Relate to the market participant's positions in expiring volatility index derivatives; (2) are for option series with the expiration that the Exchange will use to calculate the exercise or final settlement value, as applicable, of the applicable volatility index derivative; (3) are for option series with strike prices approximating the range of series that are later determined to constitute the constituent option series
Conversely, the proposal defines a non-strategy order to mean any order (including an order in a constituent option series) a market participant submits for participation in the modified opening procedure on exercise settlement value determination days that is not a strategy order (or a change to or cancellation of a strategy order).
The Exchange notes the proposed rule change would not impact a Trading Permit Holder's (“TPH”) requirements to abide by Exchange Rules 4.1 (Just and Equitable Principles of Trade), 4.7 (Manipulation), and 4.18 (Prevention of the Misuse of Material, Nonpublic Information).
After careful review, the Commission finds that the proposed rule change is consistent with the requirements of the Act,
The Commission believes that by more clearly identifying what constitutes a strategy order, and by defining a non-strategy order to include, among other things, orders in a constituent option series that offset an imbalance identified in an EOI, as described above, the proposed rule
Further, the Commission notes that TPHs will continue to be subject to Exchange Rules 4.1 (Just and Equitable Principles of Trade), 4.7 (Manipulation), and 4.18 (Prevention of the Misuse of Material, Nonpublic Information).
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
On August 27, 2018, The Nasdaq Stock Market LLC (“Nasdaq” or “Exchange”) filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
Section 19(b)(2) of the Act
The Commission finds it appropriate to designate a longer period within which to take action on the proposed rule change so that it has sufficient time to consider this proposed rule change and Amendment No. 1 thereto. Accordingly, the Commission, pursuant to Section 19(b)(2) of the Act,
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 proposed rule change consists of proposed modifications to the FICC Government Securities Division (“GSD”) Rulebook (“Rules”)
In its filing with the Commission, the clearing agency 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 clearing agency has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
FICC received approval from the Commission to implement its CCIT Service in May 2017.
Currently, CCIT Members are required to satisfy their Funds-Only Settlement Amount obligations (both debits and credits) using the same process that Netting Members are required to use for the same purpose.
FICC understands that some prospective CCIT Members do not have business relationships established with Funds-Only Settling Banks that would permit the Funds-Only Settling Banks to settle such prospective CCIT Members' Funds-Only Settlement Amount debits. Therefore, such prospective CCIT Members are currently unable to participate in the CCIT Service unless an alternative mechanism for them to satisfy their Funds-Only Settlement Amount debits directly with FICC, rather than through a Funds-Only Settling Bank, is permitted by FICC. Specifically, FICC is proposing to allow prospective CCIT Members to satisfy their Funds-Only Settlement Amount debits with FICC through the invoicing process applicable to Comparison-Only Members under Rule 25 (the “invoicing process”).
In order to effectuate the proposed rule change, FICC proposes to revise Rule 3B, Section 13 to describe that a CCIT Member may elect to pay its Funds-Only Settlement Amount debits using the invoicing process applicable to Comparison-Only Members under Rule 25 in lieu of the process described in Section 5 of Rule 13. In addition, Rule 3B, Section 13 would be revised to state that, if the CCIT Member elects the invoicing process, the CCIT Member's Funds-Only Settling Bank shall no longer be responsible for processing Funds-Only Settlement Amounts that are debits for such CCIT Member.
FICC believes that the proposed rule change is consistent with the requirements of the Act and the rules and regulations thereunder applicable to a registered clearing agency. In particular, FICC believes that the proposed rule change is consistent with Section 17A(b)(3)(F) of the Act.
FICC believes this proposed rule change to enable CCIT Members to elect the invoicing process to pay their Funds-Only Settlement Amount debits in connection with their CCIT Transactions could have an impact on competition. FICC believes that the proposed rule change could promote competition. At this time, there are entities that have expressed an interest
FICC does not believe that not providing the alternative mechanism to Netting Members would create a burden on competition. Netting Members, as full-service Members, are able to avail themselves of the existing Funds-Only Settling Bank process for Funds-Only Settlement Amount debits and credits. This existing process is automated and efficient, and FICC does not believe that Netting Members would desire to switch to an invoicing process nor would FICC allow them do so given their ability to participate in the current Funds-Only Settling Bank process.
Written comments relating to this proposed rule change have not been solicited or received. FICC will notify the Commission of any written comments received by FICC.
The foregoing rule change has become effective pursuant to Section 19(b)(3)(A) of the Act
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.
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 Creations Units in-kind in a master-feeder structure.
Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090; Applicants: Robert Tull, ProcureAM, LLC, 16 Firebush Road, Levittown, PA 19056.
Deepak T. Pai, Senior Counsel, at (202) 551-6876, 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) secondary market trading in shares does not involve a Fund as a party and will not result in dilution of an investment in shares, and (b) to the extent different prices exist during a given trading day, or from day to day, such variances occur as a result of third-party market forces, such as supply and demand. Therefore, applicants assert that secondary market transactions in shares will not lead to discrimination or preferential treatment among purchasers. Finally, applicants represent that share market prices will be disciplined by arbitrage opportunities, which should prevent shares from trading at a material discount or premium from NAV.
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 persons that are Affiliated Persons, or Second-Tier Affiliates, 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
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) of the Securities Exchange Act of 1934 (the “Act”),
The Exchange filed a proposal to list and trade shares of the FormulaFolios Sector Rotation ETF (the “Fund”), a series of the Northern Lights Fund Trust IV (the “Trust”), under Rule 14.11(i) (“Managed Fund Shares”). The shares of the Fund are referred to herein as the “Shares.”
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 Exchange proposes to list and trade the Shares under Rule 14.11(i), which governs the listing and trading of Managed Fund Shares on the Exchange.
The Shares will be offered by the Trust, which was established as a Delaware statutory trust on June 2, 2015. FormulaFolio Investments, LLC (the “Adviser”) is the investment adviser to the Fund. The Trust is registered with the Commission as an open-end investment company and has filed a registration statement on behalf of the Fund on Form N-1A (“Registration Statement”) with the Commission.
Rule 14.11(i)(7) provides that, if the investment adviser to the investment company issuing Managed Fund Shares is affiliated with a broker-dealer, such investment adviser shall erect and maintain a “fire wall” between the investment adviser and the broker-dealer with respect to access to information concerning the composition and/or changes to such investment company portfolio.
The Fund intends to qualify each year as a regulated investment company under Subchapter M of the Internal Revenue Code of 1986, as amended.
According to the Registration Statement, the Fund will be an actively managed exchange-traded fund that will seek to provide a long-term total return which exceeds the total return of its Primary Benchmark Index.
The Adviser allocates the Fund's assets based on two proprietary investment models. The Adviser's first investment model identifies trends for the individual sectors within its Primary Benchmark Index. Each month, the model analyzes the strength of the US economy and ranks the sectors of its Primary Benchmark Index based on a blend of various technical momentum indicators, volatility gauges, and valuation multiples. When the economy appears healthy, sectors with the highest risk-adjusted returns (lower volatility and higher price momentum) and the lowest valuations (lower price ratios) are ranked higher. When the economy appears unhealthy, sectors with more stable price movements and lower volatility are ranked higher. The Fund invests in the top four sectors in an equal weight. In order to achieve such exposure, the Fund will use OTC swap contracts that reference each applicable sector index (“Sector Swaps”).
In the event that such Sector Swaps are unavailable or the pricing for such contracts are unfavorable, the Fund may attempt to replicate the desired equity exposure by purchasing some or all of the equity securities that are listed on a U.S. national securities exchange, including ETFs,
The Adviser's second investment model is used to manage an active bond allocation exclusively through holding fixed income ETFs. This model analyzes various major fixed income asset classes (U.S. treasuries, investment grade U.S. bonds, high-yield U.S. bonds, high-yield municipal bonds, and floating rate bonds) based on a blend of yield spreads, interest rates, and price momentum. Following the ranking process, the Fund will invest in ETFs based on the highest-ranked asset classes, with the lowest ranked asset classes left out of the Fund.
The Fund's investments, including derivatives, will be consistent with the 1940 Act and the Fund's investment objective and policies and will not be used to enhance leverage (although certain derivatives and other investments may result in leverage).
As noted above, the Fund may also hold certain equity securities and cash and Cash Equivalents in compliance with Rules 14.11(i)(4)(C)(i)(a) and 14.11(i)(4)(C)(iii).
The Exchange represents that, except for the exception to BZX Rule 14.11(i)(4)(C)(v) described above, the Fund's proposed investments will satisfy, on an initial and continued listing basis, all of the generic listing standards under BZX Rule 14.11(i)(4)(C) and all other applicable requirements for Managed Fund Shares under Rule 14.11(i). The Trust is required to comply with Rule 10A-3 under the Act for the initial and continued listing of the Shares of the Fund. In addition, the Exchange represents that the Shares of the Fund will comply with all other requirements applicable to Managed Fund Shares including, but not limited to, requirements relating to the dissemination of key information such as the Disclosed Portfolio, Net Asset Value, and the Intraday Indicative Value, rules governing the trading of equity securities, trading hours, trading halts, surveillance, firewalls, and the information circular, as set forth in Exchange rules applicable to Managed Fund Shares and the orders approving such rules. At least 100,000 Shares will be outstanding upon the commencement of trading.
Moreover, all of the equity securities held by the Fund will trade on markets that are a member of Intermarket Surveillance Group (“ISG”) or affiliated with a member of ISG or with which the Exchange has in place a comprehensive surveillance sharing agreement.
As noted above, the Fund will comply with the requirements for Managed Fund Shares related to Disclosed Portfolio, Net Asset Value, and the Intraday Indicative Value. Additionally, the intra-day, closing and settlement prices of exchange-traded portfolio assets, including equity securities, will be readily available from the securities exchanges trading such securities, automated quotation systems, published or other public sources, or online information services such as Bloomberg or Reuters. Intraday price quotations on OTC swaps and fixed income instruments are available from major broker-dealer firms and from third-parties, which may provide prices free with a time delay or in real-time for a paid fee. Price information for Cash Equivalents will be available from major market data vendors. The Disclosed Portfolio will be available on the issuer's website free of charge. The Fund's website includes a form of the prospectus for the Fund and additional information related to NAV and other applicable quantitative information. Information regarding market price and trading volume of the Shares will be continuously available throughout the day on brokers' computer screens and other electronic services. Quotation and last sale information on the Shares will be available through the Consolidated Tape Association. Information regarding the previous day's closing price and trading volume for the Shares will be published daily in the financial section of newspapers.
Trading in the Shares may be halted for market conditions or for reasons that, in the view of the Exchange, make trading inadvisable. The Exchange deems the Shares to be equity securities, thus rendering trading in the Shares subject to the Exchange's existing rules governing the trading of equity securities. The Exchange has appropriate rules to facilitate trading in the shares during all trading sessions.
Prior to the commencement of trading, the Exchange will inform its members in an Information Circular of the special characteristics and risks associated with trading the Shares. Specifically, the Information Circular will discuss the following: (1) The procedures for purchases and redemptions of Shares in Creation Units (and that Shares are not individually redeemable); (2) BZX Rule 3.7, which imposes suitability obligations on Exchange members with respect to recommending transactions in the Shares to customers; (3) how information regarding the Intraday Indicative Value and the Disclosed Portfolio is disseminated; (4) the risks involved in trading the Shares during the Pre-Opening
In addition, the Information Circular will advise members, prior to the commencement of trading, of the prospectus delivery requirements applicable to the Fund. Members purchasing Shares from the Fund for resale to investors will deliver a prospectus to such investors. The Information Circular will also discuss any exemptive, no-action and interpretive relief granted by the Commission from any rules under the Act.
In addition, the Information Circular will reference that the Fund is subject
The Exchange believes that the proposal is consistent with Section 6(b) of the Act
The Exchange believes that the proposed rule change is designed to prevent fraudulent and manipulative acts and practices, to promote just and equitable principles of trade, to foster cooperation and coordination with persons engaged in facilitating transactions in securities, 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 in that the Shares will meet each of the initial and continued listing criteria in BZX Rule 14.11(i) except that the Fund may not comply with Rule 14.11(i)(4)(C)(v).
Trading of the Shares through the Exchange will be subject to the Exchange's surveillance procedures for derivative products, including Managed Fund Shares. All of the equity securities held by the Fund will trade on markets that are a member of ISG or affiliated with a member of ISG or with which the Exchange has in place a comprehensive surveillance sharing agreement. The Exchange, FINRA, on behalf of the Exchange, or both will communicate regarding trading in the Shares and the underlying equity securities held by the Fund with the ISG, other markets or entities who are members or affiliates of the ISG, or with which the Exchange has entered into a comprehensive surveillance sharing agreement.
The Exchange notes that the Fund will meet and be subject to all other requirements of the Generic Listing Rules and other applicable continued listing requirements for Managed Fund Shares under Rule 14.11(i), including those requirements regarding the Disclosed Portfolio and the requirement that the Disclosed Portfolio and the NAV will be made available to all market participants at the same time,
For the above reasons, the Exchange believes that the proposed rule change is consistent with the requirements of Section 6(b)(5) of the Act.
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 purpose of the Act. The Exchange notes that the proposed rule change, rather will facilitate the listing and trading of an additional actively-managed exchange-traded product that will enhance competition among both market participants and listing venues, to the benefit of investors and the marketplace.
The Exchange has neither solicited nor received written comments on the proposed rule change.
Within 45 days of the date of publication of this notice in the
(A) by order approve or disapprove the proposed rule change, or
(B) institute proceedings to determine whether the proposed rule change should be disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1)
The Exchange proposes to amend its Schedule of Fees and Rebates to adopt the same billing dispute practice as the Exchange's affiliates and other exchanges. 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 its Schedule of Fees and Rebates to adopt the same billing dispute practice as the Exchange's affiliates and other exchanges. As discussed below, the proposed provision would be identical to provision [sic] in the fee schedules of the Exchange's affiliates the New York Stock Exchange LLC (“NYSE”), NYSE Arca, Inc. (“NYSE Arca”), and NYSE American LLC (“NYSE American”) as well as other equities and options exchanges.
The Exchange proposes to amend its Schedule of Fees and Rebates to adopt a billing procedure to prevent ETP Holders from contesting their bills long after they have been sent an invoice. The procedure proposed by the Exchange is the same as that in place at the Exchange's equities and options affiliates
As proposed, all fee disputes concerning fees billed by the Exchange would have to be submitted to the Exchange in writing and accompanied by supporting documentation. Further, all fee disputes would have be [sic] submitted no later than sixty (60) days after receipt of a billing invoice. After sixty days, all fees assessed by the Exchange would be considered final. The Exchange believes that this requirement, which is the same as that in place at the Exchange's equities and options market affiliates,
The Exchange believes it is reasonable for ETP Holders to become aware of any potential billing errors within sixty calendar days of receiving an invoice. Requiring that ETP Holders dispute an invoice within this time period will encourage ETP Holders to review their invoices promptly so that any disputed charges can be addressed in a timely manner while the information and data underlying those charges (
In order for ETP Holders to be fully aware of this rule regarding fee disputes, the Exchange proposes to include the language proposed for the Schedule of Fees and Rebates in each customer invoice.
The Exchange believes that the proposed rule change is consistent with Section 6(b) of the Act,
The Exchange believes the requirement to submit all billing disputes in writing, and with supporting documentation, within sixty days from receipt of the invoice, is reasonable because the Exchange provides ample tools to properly and swiftly monitor and account for various charges incurred in a given month. Also, the proposal is equitable and not unfairly discriminatory because it applies equally to all ETP Holders. The proposed provision regarding fee disputes in the Schedule of Fees and Rebates promotes the protection of investors and the public interest by providing a clear and concise mechanism in Exchange Rules for ETP Holders to dispute fees and for the Exchange to review such disputes in a timely manner. In addition, the proposed 60-day limitation is fair and equitable because it will be implemented prospectively on all ETP Holders, only applying to invoices issued after the proposed rule change becomes operative. Moreover, the proposed billing dispute language, which will lower the Exchange's administrative burden, is the same as the billing dispute language adopted by the NYSE Affiliates as well as other exchanges.
For the foregoing reasons, the Exchange believes that the proposal is consistent with the Act.
In accordance with Section 6(b)(8) of the Act,
No written comments were solicited or received with respect to the proposed rule change.
The Exchange has filed the proposed rule change pursuant to Section 19(b)(3)(A)(iii) of the Act
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
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (the “Act”),
The Exchange filed a proposal to amend the Exchange's fee schedule applicable to its equities trading platform (“EDGX Equities”) to eliminate the Investor Depth Tier.
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 EDGX Equities fee schedule offers seven Add Volume Tiers that provide enhanced rebates, ranging from of $0.0025 to $0.0032 per share, for displayed orders that add liquidity in Tapes A, B, and C and yield fee codes B,
The Exchange believes that its proposal is consistent with Section 6 of the Act,
The Exchange believes that the proposed elimination of the Investor Depth Tier is reasonable and equitable as this tier has not been successful in attracting the required order flow to the Exchange. As explained in the purpose section of this proposed rule change, the Exchange offers a range of Add Volume Tiers that provide enhanced rebates to qualifying displayed orders that add liquidity in Tape A, B, and C securities. These tiers are designed to encourage more active participation on the Exchange by providing higher rebates to Members that meet specified requirements. The Investor Depth Tier, in particular, was designed to encourage Members to bring different types of order flow to the Exchange, including both displayed and non-displayed liquidity. However, this tier has not been successful in attracting the required order flow. The Exchange therefore believes that it is appropriate to eliminate this tier at this time. The Exchange also believes that the proposed fee change is equitable and not unfairly discriminatory as it applies to all Members on an equal basis. With the proposed change, no Member would be eligible for an enhanced rebate based on meeting the requirements of the eliminated Investor Depth Tier. Members will continue to be able to achieve enhanced rebates for displayed orders that add liquidity by meeting the requirements of any of the six remaining Add Volume Tiers. In addition, Members that do not meet the requirements for any of the Add Volume Tiers will continue to be paid the standard rebate applicable to fee codes B, V, Y, 3 and 4.
The Exchange does not believe that the proposed rule change will result in any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act, as amended. The proposed elimination of the Investor Depth Tier is designed to remove an incentive that the Exchange believes was not successful, and will apply to all Members. The Exchange operates in a highly competitive market in which market participants can readily direct their order flow to competing venues. In such an environment, the Exchange must continually review, and consider adjusting, its fees and rebates to remain competitive with other exchanges. For the reasons described above, the Exchange believes that the proposed fee changes reflect this competitive environment.
No written comments were either solicited or received.
The foregoing rule change has become effective pursuant to Section 19(b)(3)(A) of the Act
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 Plexus Fund IV-C, L.P., 4242 Six Forks Road, Suite 950, Raleigh, NC 27609, a Federal Licensee under the Small Business Investment Act of 1958, as amended (“the Act”), in connection with the financing of a small concern, has sought an exemption under Section 312 of the Act and Section 107.730, Financings which Constitute Conflicts of Interest of the Small Business Administration (“SBA”) Rules and Regulations (13 CFR 107.730). Plexus Fund IV-C, L.P. is seeking a prior written exemption from SBA to make a debt financing to Rotolo Consultants, Inc., 894 Robert Blvd., Slidell, LA 70458.
The financing is brought within the purview of § 107.730(a)(1) of the Regulations because Plexus Fund III, L.P., and Plexus Fund QP III, L.P., Associates of Plexus Fund IV-C, L.P., each own more than ten percent of Rotolo Consultants, Inc., and therefore this transaction is considered
Notice is hereby given that any interested person may submit written comments on this transaction within fifteen days of the date of this publication to the Associate Administrator, Office of Investment and Innovation, U.S. Small Business Administration, 409 Third Street SW, Washington, DC 20416.
U.S. Small Business Administration.
Notice.
This is a Notice of the Presidential declaration of a major disaster for Public Assistance Only for the Commonwealth of Virginia (FEMA-4401-DR), dated 10/15/2018.
Issued on 10/15/2018.
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 President's major disaster declaration on 10/15/2018, Private Non-Profit organizations that provide essential services of a governmental nature may file disaster loan applications 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 157488 and for economic injury is 157490.
U.S. Small Business Administration.
Amendment 3.
This is an amendment of the Presidential declaration of a major disaster for the State of Florida (FEMA-4399-DR), dated 10/11/2018.
Issued on 10/16/2018.
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.
The notice of the President's major disaster declaration for the State of Florida, dated 10/11/2018, is hereby amended to include the following areas as adversely affected by the disaster:
All other information in the original declaration remains unchanged.
U.S. Small Business Administration.
Amendment 5.
This is an amendment of the Presidential declaration of a major disaster for the State of North Carolina (FEMA-4393-DR), dated 09/14/2018. Incident: Hurricane Florence. Incident Period: 09/07/2018 through 09/29/2018.
Issued on 10/14/2018.
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.
The notice of the President's major disaster declaration for the State of North Carolina, dated 09/14/2018, is hereby amended to include the following areas as adversely affected by the disaster:
All other information in the original declaration remains unchanged.
Notice is hereby given that Plexus Fund IV-A, L.P., 4242 Six Forks Road, Suite 950, Raleigh, NC 27609, a Federal Licensee under the Small Business Investment Act of 1958, as amended (“the Act”), in connection with the financing of a small concern, has sought an exemption under Section 312 of the Act and Section 107.730, Financings which Constitute Conflicts of Interest of the Small Business Administration (“SBA”) Rules and Regulations (13 CFR 107.730). Plexus Fund IV-A, L.P. is seeking a prior written exemption from SBA to make a debt financing to Rotolo Consultants, Inc., 894 Robert Blvd., Slidell, LA 70458.
The financing is brought within the purview of § 107.730(a)(1) of the Regulations because Plexus Fund III, L.P., and Plexus Fund QP III, L.P., Associates of Plexus Fund IV-A, L.P., each own more than ten percent of Rotolo Consultants, Inc., and therefore this transaction is considered
Notice is hereby given that any interested person may submit written comments on this transaction within fifteen days of the date of this publication to the Associate Administrator, Office of Investment and Innovation, U.S. Small Business Administration, 409 Third Street SW, Washington, DC 20416.
Notice is hereby given that Plexus Fund IV-B, L.P., 4242 Six Forks Road, Suite 950, Raleigh, NC 27609, a Federal Licensee under the Small Business Investment Act of 1958, as amended (“the Act”), in connection with the financing of a small concern, has sought an exemption under Section 312 of the Act and Section 107.730, Financings which Constitute Conflicts of Interest of the Small Business Administration (“SBA”) Rules and Regulations (13 CFR 107.730). Plexus Fund IV-B, L.P. is seeking a prior written exemption from SBA to make a debt financing to Rotolo Consultants, Inc., 894 Robert Blvd., Slidell, LA 70458.
The financing is brought within the purview of § 107.730(a)(1) of the Regulations because Plexus Fund III, L.P., and Plexus Fund QP III, L.P., Associates of Plexus Fund IV-B, L.P., each own more than ten percent of Rotolo Consultants, Inc., and therefore this transaction is considered
Notice is hereby given that any interested person may submit written comments on this transaction within fifteen days of the date of this publication to the Associate Administrator, Office of Investment and Innovation, U.S. Small Business Administration, 409 Third Street SW, Washington, DC 20416.
The Social Security Administration (SSA) publishes a list of information collection packages requiring clearance by the Office of Management and Budget (OMB) in compliance with Public Law 104-13, the Paperwork Reduction Act of 1995, effective October 1, 1995. This notice includes an extension and revisions of OMB-approved information collections, and one new information collection.
SSA is soliciting comments on the accuracy of the agency's burden estimate; the need for the information; its practical utility; ways to enhance its quality, utility, and clarity; and ways to minimize burden on respondents, including the use of automated collection techniques or other forms of information technology. Mail, email, or fax your comments and recommendations on the information collection(s) to the OMB Desk Officer and SSA Reports Clearance Officer at the following addresses or fax numbers.
Or you may submit your comments online through
I. The information collections below are pending at SSA. SSA will submit them to OMB within 60 days from the date of this notice. To be sure we consider your comments, we must receive them no later than December 21, 2018. Individuals can obtain copies of the collection instruments by writing to the above email address.
II. SSA submitted the information collection below to OMB for clearance. Your comments regarding this information collections would be most useful if OMB and SSA receive them 30 days from the date of this publication. To be sure we consider your comments, we must receive them no later than November 21, 2018. Individuals can obtain copies of the OMB clearance packages by writing to
The Department of State announces a meeting of the U.S. State Department Overseas Security Advisory Council on November 13, 2018. Pursuant to Section 10(d) of the Federal Advisory Committee Act (5 U.S.C. Appendix), 5 U.S.C. 552b(c)(4), and 5 U.S.C. 552b(c)(7)(E), it has been determined that the meeting will be closed to the public. The meeting will focus on an examination of corporate security policies and procedures and will involve extensive discussion of trade secrets and proprietary commercial information that is privileged and confidential, and will discuss law enforcement investigative techniques and procedures. The agenda will include updated committee reports, a global threat overview, and other matters relating to private sector security policies and protective programs and the protection of U.S. business information overseas.
For more information, contact Marsha Thurman, Overseas Security Advisory Council, U.S. Department of State, Washington, DC 20522-2008, phone: 571-345-2214.
The Department of State has renewed the Charter of the Overseas Security Advisory Council. This federal advisory committee will continue to interact on overseas security matters of mutual interest between the U.S. Government and the American private sector. The Council's initiatives and security publications provide a unique contribution to protecting American private sector interests abroad. The Under Secretary for Management determined that renewal of the Charter is necessary and in the public interest.
The Council consists of representatives from three (3) U.S. Government agencies and thirty-one (31) American private sector companies and organizations. The Council follows the procedures prescribed by the Federal Advisory Committee Act (FACA) (Pub. L. 92-463). Meetings will be open to the public unless a determination is made in accordance with Section 10(d) of the FACA and 5 U.S.C. 552b, that a meeting or a portion of the meeting should be closed to the public. Notice of each meeting will be provided in the
For more information contact Marsha Thurman, Overseas Security Advisory Council, Bureau of Diplomatic Security, U.S. Department of State, Washington, DC 20522-2008, phone: 571-345-2214.
Notice is hereby given of the following determinations: I hereby determine that certain objects to be included in the exhibition “The Jeweled Isle: Art from Sri Lanka,” imported from abroad for temporary exhibition within the United States, are of cultural significance. The objects are imported pursuant to loan agreements with the foreign owners or custodians. I also determine that the exhibition or display of the exhibit objects at the Los Angeles County Museum of Art, Los Angeles, California, from on or about December 9, 2018, until on or about June 23, 2019, and at possible additional exhibitions or venues yet to be determined, is in the national interest. I have ordered that Public Notice of these determinations be published in the
Julie Simpson, Attorney-Adviser, Office of the Legal Adviser, U.S. Department of State (telephone: 202-632-6471; email:
The foregoing determinations were made pursuant to the authority vested in me by the Act of October 19, 1965 (79 Stat. 985; 22 U.S.C. 2459), E.O. 12047 of March 27, 1978, the Foreign Affairs Reform and Restructuring Act of 1998 (112 Stat. 2681,
The Surface Transportation Board has received a request from Neville Peterson LLP on behalf of Trinity Industries, Inc. (WB18-33—10/16/18) for permission to use data from the Board's 2017 Masked Carload Waybill Sample. A copy of this request may be obtained from the Board's website under docket no. WB18-33.
The waybill sample contains confidential railroad and shipper data; therefore, if any parties object to these requests, they should file their objections with the Director of the
Contact: Alexander Dusenberry, (202) 245-0319.
Federal Aviation Administration (FAA), DOT.
Notice.
This notice contains a summary of a petition seeking relief from specified requirements of Title 14 of the Code of Federal Regulations. The purpose of this notice is to improve the public's awareness of, and participation in, the FAA's exemption process. Neither publication of this notice nor the inclusion or omission of information in the summary is intended to affect the legal status of the petition or its final disposition.
Comments on this petition must identify the petition docket number and must be received on or before November 13, 2018.
Send comments identified by docket number FAA-2018-0734 using any of the following methods:
•
•
•
•
Jake Troutman, (202) 683-7788, 800 Independence Avenue SW, Washington, DC 20591.
This notice is published pursuant to 14 CFR 11.85.
Federal Aviation Administration (FAA), DOT.
Notice; correction.
The FAA published a document in the
Mark Forseth, AIR-673, Federal Aviation Administration, 2200 South 216th Street, Des Moines, WA 98198, phone and fax 206-231-3179, email
In Summary Notice No. PE-2018-76, published in the
Federal Aviation Administration (FAA), Department of Transportation (DOT).
Notice.
This notice contains a summary of a petition seeking relief
Comments on this petition must identify the petition docket number and must be received on or before November 13, 2018.
Send comments identified by docket number FAA-2018-0619 using any of the following methods:
•
•
•
•
Jake Troutman, (202) 683-7788, Office of Rulemaking, Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC 20591.
This notice is published pursuant to 14 CFR 11.85.
Federal Aviation Administration (FAA), DOT.
Notice.
The Federal Aviation Administration is requesting public comment on a request by the City of Murfreesboro, to release approximately 1.28 acres of land at the Murfreesboro Municipal Airport from federal obligations. The request consists of 1.28 acres of parcel “1” as shown on the Approved Exhibit A property map. The parcel is situated westward from the terminal area, lying along the south side of the main access road to the airport from Memorial Boulevard (US Highway 231). Parcel “1” was acquired by the City of Murfreeboro by Deed dated May 26, 1947, which included 237.25 acres of the original airport. This request will release 1.28 acres of this property from federal obligations.
Comments must be received on or before November 21, 2018.
Comments on this notice may be mailed or delivered in triplicate to the FAA at the following address: Memphis Airports District Office, Attn: Jamal Stovall, Community Planner, 2600 Thousand Oaks Boulevard, Suite 2250, Memphis, TN 38118.
In addition, one copy of any comments submitted to the FAA must be mailed or delivered to Mr. Chad L. Gehrke, Airport Manager, Murfreesboro Municipal Airport at the following address: Murfreesboro Municipal Airport, 1930 Municipal Boulevard, Murfreesboro, TN 37129.
Mr. Jamal Stovall, Community Planner, Federal Aviation Administration, Memphis Airports District Office, 2600 Thousand Oaks Boulevard, Suite 2250, Memphis, TN 38118-2482. The application may be reviewed in person at this same location, by appointment.
The FAA proposes to rule and invites public comment on the request to release property for disposal at the Murfreesboro Municipal Airport, 1930 Memorial Boulevard, Murfreesboro, TN 37129, under the provisions of 49 U.S.C. 47107(h)(2). The FAA determined that the request to release property at the Murfreesboro Municipal Airport, (MBT) submitted by the Sponsor meets the procedural requirements of the Federal Aviation Administration and the release of the property does not and will not impact future aviation needs at the airport. The FAA may approve the request, in whole or in part, no sooner than thirty days after the publication of this notice.
The following is a brief overview of the request:
The City of Murfreesboro is releasing approximately 1.28 acres of property fronting U.S. Highway 231 (Memorial Boulevard) and Airport Road. This request will release this property from federal obligations.
Any person may inspect the request in person at the FAA office listed above under
In addition, any person may, upon request, inspect the request, notice and other documents germane to the request in person at the Murfreesboro Municipal Airport, 1930 Memorial Boulevard, Murfreesboro, TN 37129.
This action is taken under the provisions of 49 U.S.C. 47107(h)(2).
Federal Aviation Administration (FAA), DOT.
Notice of petition for exemption received.
This notice contains a summary of a petition seeking relief from specified requirements of Federal Aviation Regulations. The purpose of this notice is to improve the public's awareness of, and participation in, the FAA's exemption process. Neither publication of this notice nor the inclusion or omission of information in the summary is intended to affect the legal status of the petition or its final disposition.
Comments on this petition must identify the petition docket number and must be received on or before November 13, 2018.
Send comments identified by docket number FAA-2018-0897 using any of the following methods:
•
•
•
•
Alana Zautner, AIR-673, Federal Aviation Administration, 2200 South 216th St., Des Moines, WA 98198, phone 206-231-3369, email
Federal Aviation Administration, DOT.
Notice of correction.
This action for NOA-18-01 corrects the designation for one of the consensus standards. NOA-18-01 announced the availability and requests comments on two new and two revised consensus standards relating to the provisions of the Sport Pilot and Light-Sport Aircraft rule.
Terry Chasteen, Light-Sport Aircraft Program Manager, Programs and Procedures, AIR-694, Small Airplane Standards Branch, Aircraft Certification Service, Federal Aviation Administration, 901 Locust, Room 301, Kansas City, Missouri 64106; telephone (816) 329-4147; email:
On October 3, 2018, the Federal Aviation Administration published Notice No. NOA-18-01 in the
Pipeline and Hazardous Materials Safety Administration (PHMSA), DOT.
Notice and request for comments.
On July 13, 2018, in accordance with the Paperwork Reduction Act of 1995, PHMSA published a notice in the
During the public comment period, PHMSA received two comments in response to the proposed revision to this information collection. PHMSA is publishing this notice to respond to the comments received and to announce that the Information Collection Request will be submitted to OMB for approval.
Interested persons are invited to submit comments on or before November 21, 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-2018-0072 by any of the following methods:
•
•
•
Requests for a copy of the Information Collection should be directed to Angela Dow by telephone at 202-366-1246, by fax at 202-366-4566, by email at
During the 60-day comment period, PHMSA received a joint comment from American Petroleum Institute (API) and the Association of Oil Pipe Lines (AOPL) and a comment from the American Gas Association. Both comments emphasized the importance of PHMSA streamlining its data collection and entry processes.
American Petroleum Institute (API) and the Association of Oil Pipe Lines (AOPL) provided a joint comment recommending that PHMSA allow operators to submit annual report data through the National Pipeline Mapping System (NPMS). However, the NPMS does not currently include all of the pipeline attributes in the annual report. Additionally, PHMSA's proposal to add attributes to the NPMS through docket PHMSA-2014-0092 is not approved by the OMB and does not include attributes for barrel-miles transported, integrity inspections, or integrity assessments. For these reasons, operators need to continue to use Parts C, F, and G of the Annual Report.
API/AOPL are proposing that PHMSA remove Part M Breakout Tanks by state, interstate/intrastate and by size. PHMSA needs to collect data on breakout tanks since the public relies on PHMSA to provide this data. The state and interstate/intrastate status of the breakout tanks is required to determine whether PHMSA or a state pipeline safety partner regulates the tanks.
API/AOPL also recommended that PHMSA allow operators to submit annual report data to the PHMSA portal by way of Secure File Transfer Protocol (SFTP). PHMSA has invested significant effort in the data collection routine currently in use. Numerous validations have been built to ensure the consistency of data among various parts of the annual report. PHMSA lacks the resources to recreate these validations in an SFTP environment. If PHMSA were to provide an SFTP submittal option, it would be extremely difficult to incorporate future changes. If the annual report were to change in the future, PHMSA would have to modify the existing data collection routine and the SFTP process.
The American Gas Association (AGA) submitted a comment in support of the joint comment submitted by API/AOPL.
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 an information collection request that PHMSA will submit to OMB for revision. The following information is provided for this 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 this information collection activity. PHMSA requests comments on the following information collection:
(a) The need for the proposed collection 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;
The Specially Designated Nationals and Blocked Persons List and additional information concerning OFAC sanctions programs are available on OFAC's website (
On September 14, 2018, OFAC determined that the property and interests in property subject to U.S. jurisdiction of the following person are blocked under the relevant sanctions authorities listed below.
1. MY AVIATION COMPANY LIMITED, 27th Floor, ITF Tower 140/65 Silom Road, Suriyawong, Bang Rak, Bangkok 10500, Thailand; Email Address
Designated pursuant to section 1(c) of E.O. 13224 for acting for or on behalf of Iran's MAHAN AIR, a person determined to be subject to E.O. 13224.
Additionally, on September 14, 2018, OFAC updated the entry on the Specially Designated Nationals and Blocked Persons List for the following entity, whose property and interests in property subject to U.S. jurisdiction continue to be blocked under the relevant sanctions authorities listed below.
MAHAN TRAVEL AND TOURISM SDN BHD (a.k.a. MAHAN TRAVEL), No.01, Lower Ground Floor, Block C, NO:12 Megan Avenue2, Jalan Yap, Kwan Seng, Kuala Lumpur, Malaysia; website
-to-
MAHAN TRAVEL AND TOURISM SDN BHD (a.k.a. MAHAN TRAVEL; a.k.a. MIHAN TRAVEL & TOURISM SDN BHD), No.01, Lower Ground Floor, Block C, NO:12 Megan Avenue2, Jalan Yap, Kwan Seng, Kuala Lumpur, Malaysia; website
Designated on July 9, 2018 pursuant to section 1(c) of E.O. 13224 for acting for or on behalf of MAHAN AIR, a person determined to be subject to E.O. 13224.
Office of Foreign Assets Control, Treasury.
Notice.
The Department of the Treasury's Office of Foreign Assets Control (OFAC) is publishing the names of three 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; Assistant Director for Regulatory Affairs, tel. 202-622-4855; 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 information concerning OFAC sanctions programs are available on OFAC's website (
On August 24, 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 authority listed below.
1. FAIZ, Mohammed Karim Yusop (a.k.a. FAIZ, Mohammad Yusuf Karim; a.k.a. FAIZ, Mohammed Yusop Karin; a.k.a. FAIZ, Mohd Karim Yusop; a.k.a. SAIFUDDIN, Muhmmad; a.k.a. “AL-INDONESI, Abu Walid”; a.k.a. “AL-INDUNISI, Abu-Walid”), Syria; DOB 11 Oct 1978; POB Indonesia; nationality Indonesia; citizen Indonesia; Gender Male (individual) [SDGT] (Linked To: ISLAMIC STATE OF IRAQ AND THE LEVANT).
Designated 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 acting for or on behalf of the ISLAMIC STATE OF IRAQ AND THE LEVANT, an entity determined to be subject to E.O. 13224.
2. KIRAM, Mohammad Reza Lahaman (a.k.a. KIRAM, Mohd Reza; a.k.a. “AL-FILIPINI, Abu Abdul Rahman”), Syria; DOB 03 Mar 1990; POB Zamboanga City, Zamboanga del Sur, Philippines; nationality Philippines; citizen Philippines; Gender Male (individual) [SDGT] (Linked To: ISLAMIC STATE OF IRAQ AND THE LEVANT).
Designated 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 acting for or on behalf of the ISLAMIC STATE OF IRAQ AND THE LEVANT, an entity determined to be subject to E.O. 13224.
3. UDIN, Mohamad Rafi (a.k.a. UDIN, Mohd Rafi; a.k.a. UDIN, Rafi; a.k.a. “AL-MALISI, Abu Awn”), Syria; DOB 03 Jun 1966; POB Negri Sembilan, Malaysia; nationality Malaysia; citizen Malaysia; Gender Male (individual) [SDGT] (Linked To: ISLAMIC STATE OF IRAQ AND THE LEVANT).
Designated 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 acting for or on behalf of the ISLAMIC STATE OF IRAQ AND THE LEVANT, an entity determined to be subject to E.O. 13224.
Notice.
The United States Mint announces an invitation stakeholder roundtable for the purpose of exchanging facts and information on the circulation of coinage. The Mint seeks information and advice on an individual basis about how coin can better circulate to reduce the commercial demand for newly minted coinage. The Mint intends to issue invitations to up to 35 participants with the objective of creating a diverse cross-section of stakeholder interests including, but not limited to, those associated with armored car carriers, coin processors, national and regional coin aggregators, financial institutions, and large retailers.
This is not a public meeting. Any member of the public interested in participating in this roundtable discussion should use the contact information in this notice to request an invitation and obtain additional meeting information. Please include a description of your interest in the subject matter and a brief description of the individual perspective that you would bring to the roundtable discussion. The Mint intends to issue invitations on a rolling basis, and thus encourages interested parties to submit requests in a timely manner and no later than close of business on Friday, November 9, 2018.
Patrick Cuddy, Senior Advisor, Office of Coin Studies at
31 U.S.C. 5136.
U.S. Department of Veterans Affairs.
Notice of intent.
The Secretary of VA intends to enter into an EUL for the purpose of outleasing Buildings #5, 6, 7, 8 and construct six new townhomes on approximately 10.52 acres of underutilized land on the Lexington VA Health Care System, Franklin R. Sousley campus, consisting of approximately 50 housing units to provide affordable housing for veterans. The EUL lessee, Leestown VA Housing, LLLP, will finance, design, develop, rehabilitate, construct, manage, maintain, and operate housing for eligible homeless veterans, or veterans at-risk of homelessness, and their families, as well as provide services that guide resident veterans toward attaining long-term self-sufficiency.
Edward L. Bradley III, Office of Asset Enterprise Management (044), Department of Veterans Affairs, 810 Vermont Avenue NW, Washington, DC 20420, (202) 461-7778 (this is not a toll free number).
Title 38 U.S.C. 8161,
The Secretary of Veterans Affairs, or designee, approved this document and authorized the undersigned to sign and submit the document to the Office of the Federal Register for publication electronically as an official document of the Department of Veterans Affairs. Robert L. Wilkie, Secretary, Department of Veterans Affairs, approved this document for publication on October 12, 2018.
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