Drawbridge Operation Regulation; Sacramento River, Sacramento, CA
The Coast Guard has issued a temporary deviation from the operating schedule that governs the Tower Drawbridge across the Sacramento River, mile 59.0, at Sacramento, CA. The deviation is necessary to allow the community to participate in the New Year's Eve Sky Spectacular fireworks show. This deviation allows the bridge to remain in the closed-to-navigation position during the deviation period.
Pacific Island Fisheries; 2017 Hawaii Kona Crab Annual Catch Limit and Accountability Measure
NMFS proposes a 2017 annual catch limit (ACL) of 3,500 lb for Hawaii Kona Crab, and an accountability measure (AM) to correct or mitigate any overages of catch limits. The proposed ACL and AM support the long-term sustainability of fishery resources of the U.S. Pacific Islands.
Certain Color Intraoral Scanners and Related Hardware and Software; Institution of Investigation
Notice is hereby given that a complaint was filed with the U.S. International Trade Commission on November 14, 2017, under section 337 of the Tariff Act of 1930, as amended, on behalf of Align Technology, Inc. of San Jose, California. An amended complaint and supplement were filed on December 4, 2017. The amended complaint alleges violations of section 337 based upon the importation into the United States, the sale for importation, and the sale within the United States after importation of certain color intraoral scanners and related hardware and software by reason of infringement of one or more of U.S. Patent No. 8,363,228 (``the '228 patent''); U.S. Patent No. 8,451,456 (``the '456 patent''); U.S. Patent No. 8,675,207 (``the '207 patent''); U.S. Patent No. 9,101,433 (``the '433 patent''); U.S. Patent No. 6,948,931 (``the '931 patent''); and U.S. Patent No. 6,685,470 (``the '470 patent''). The amended complaint further alleges that an industry in the United States exists as required by the applicable Federal Statute. The complainant requests that the Commission institute an investigation and, after the investigation, issue a limited exclusion order and cease and desist orders.
Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use
The Food and Drug Administration (FDA, the Agency, or we) is issuing this final rule establishing that certain active ingredients used in nonprescription (also known as over-the-counter or OTC) antiseptic products intended for use by health care professionals in a hospital setting or other health care situations outside the hospital are not generally recognized as safe and effective (GRAS/GRAE). FDA is issuing this final rule after considering the recommendations of the Nonprescription Drugs Advisory Committee (NDAC); public comments on the Agency's notices of proposed rulemaking; and all data and information on OTC health care antiseptic products that have come to the Agency's attention. This final rule finalizes the 1994 tentative final monograph (TFM) for OTC health care antiseptic drug products that published in the Federal Register of June 17, 1994 (the 1994 TFM) as amended by the proposed rule published in the Federal Register (FR) of May 1, 2015 (2015 Health Care Antiseptic Proposed Rule (PR)).
Hours of Service; Electronic Logging Devices; Limited 90-Day Waiver for the Transportation of Agricultural Commodities
FMCSA grants a limited 90-day waiver from the Federal hours- of-service (HOS) regulations pertaining to electronic logging devices (ELDs) for the transportation of agricultural commodities as defined in the Federal Motor Carrier Safety Regulations (FMCSRs). The Agency takes this action in response to a waiver request from the National Pork Producers Council (NPPC) on behalf of eight organizations representing transporters of livestock and other agricultural commodities, as defined in the FMCSRs. The Agency has determined that the waiver is in the public interest and would likely achieve a level of safety that is equivalent to, or greater than, the level that would be achieved absent such exemption, based on the terms and conditions imposed. The waiver will also through notice and public comment, provide FMCSA with time to consider certain exemption applications from segments of the agricultural industry concerning the use of ELDs to document drivers' hours of service and clarify applicability of the requirements and the need for certain carriers to begin using ELDs by the December 18, 2017, deadline.
Hours of Service of Drivers of Commercial Motor Vehicles; Proposed Regulatory Guidance Concerning the Transportation of Agricultural Commodities
FMCSA announces regulatory guidance to clarify the applicability of the ``Agricultural commodity'' exception to the ``Hours of Service of Drivers'' regulations, and requests public comments. This regulatory guidance is being proposed to ensure consistent understanding and application of the exception by motor carriers and State officials enforcing hours of service rules identical to or compatible with FMCSA's requirements.
Safety Zone; Pacific Ocean, Kilauea Lava Flow Ocean Entry on Southeast Side of Island of Hawaii, HI
On April 3, 2017, the Coast Guard published a notice of proposed rulemaking to establish a permanent safety zone surrounding the entry of lava from the Kilauea volcano into the Pacific Ocean on the southeast side of the Island of Hawaii, HI. The safety zone is needed to protect persons and vessels from the potential hazards associated with molten lava entering the ocean. After considering comments received from the public, the Coast Guard analyzed the economic impact of the proposed rule and made minor modifications to the proposed rule. This supplemental notice requests comments on the analysis and revised proposal.
Notice of Availability of the Deepwater Horizon Oil Spill Louisiana Trustee Implementation Group Draft Strategic Restoration Plan and Environmental Assessment #3: Restoration of Wetlands, Coastal and Nearshore Habitats in the Barataria Basin, Louisiana
In accordance with the Oil Pollution Act of 1990 (OPA), the National Environmental Policy Act (NEPA), and a Consent Decree with BP Exploration & Production Inc. (BP), the Deepwater Horizon Federal and State natural resource trustee agencies for the Louisiana Trustee Implementation Group (Louisiana TIG) have prepared the Draft Strategic Restoration Plan and Environmental Assessment #3: Restoration of Wetlands, Coastal, and Nearshore Habitats in the Barataria Basin, Louisiana (SRP/EA). The Draft SRP/EA identifies a restoration strategy that will help prioritize future decisions regarding project selection and funding. Rather than selecting specific projects for construction, the Trustees evaluate a suite of restoration techniques and approaches, for example large-scale diversions or marsh creation, to determine how to best support restoring ecosystem-level injuries in the Gulf of Mexico through restoration in the Barataria Basin. The purpose of this notice is to inform the public of the availability of the Draft SRP/EA and to seek public comments on the document.
Airworthiness Directives; Airbus Helicopters (Previously Eurocopter France)
We are superseding Airworthiness Directive (AD) 2009-25-07 for Airbus Helicopters Model EC120B helicopters. AD 2009-25-07 required amending the rotorcraft flight manual supplement (RFMS) and pre-flight checking the emergency flotation gear before each flight over water. Since we issued AD 2009-25-07, Airbus Helicopters developed a terminating action and identified an additional part- numbered emergency floatation gear part with the unsafe condition. This new AD retains the requirements of AD 2009-25-07, expands the applicability, and adds a terminating action for the repetitive inspections. The actions of this AD are intended to correct an unsafe condition on these helicopters.
Training, Qualification, and Oversight for Safety-Related Railroad Employees
In response to a petition for reconsideration of a final rule, FRA proposes to amend its regulations (Training, Qualification, and Oversight for Safety-Related Railroad Employees) by delaying certain implementation dates an additional year. FRA previously delayed the regulations' implementation dates for one year in a final rule published May 3, 2017 (May 2017 Final Rule).
Airworthiness Directives; The Enstrom Helicopter Corporation Helicopters
We are adopting a new airworthiness directive (AD) for the Enstrom Helicopter Corporation (Enstrom) Model F-28, F-28A, F-28C, F- 28C-2, F-28C-2R, F-28F, F-28F-R, TH-28, 280, 280C, 280F, 280FX, 480, and 480B helicopters. This AD requires inspecting certain rod end bearing assemblies. This AD is prompted by an accident. The actions of this AD are intended to prevent an unsafe condition on these helicopters.
Airworthiness Directives; Agusta S.p.A. Helicopters
We are superseding airworthiness directive (AD) 2011-27-08 for Agusta S.p.A. (Agusta) Model A109S and AW109SP helicopters. AD 2011-27- 08 required repetitively inspecting each elevator assembly for a crack. This new AD retains the initial inspection interval and adds a repetitive borescope inspection. This AD is prompted by the discovery of another crack on an elevator assembly since AD 2011-27-08 was issued. The actions of this AD are intended to prevent an unsafe condition on these helicopters.
Change to Automatic Dependent Surveillance Broadcast Services
This action announces changes in ADS-B services, including Traffic Information ServiceBroadcast (TIS-B), for a small number of aircraft. The FAA is implementing a filter for certain ADS-B equipped aircraft broadcasting erroneous or improper information when the broadcast information could affect the safe provision of air traffic services. Any aircraft subject to the filter will not have its ADS-B information sent to an air traffic control (ATC) facility nor will the aircraft be a client for TIS-B services. Affected aircraft will continue to receive ATC services within radar coverage using secondary radar information.
Airworthiness Directives; The Boeing Company Airplanes
We are adopting a new airworthiness directive (AD) for certain The Boeing Company Model 757-200 series airplanes. This AD was prompted by a report indicating that the main cargo door (MCD) forward-most cam latch on the forward center cam latch pair broke during flight. This AD requires repetitive inspections for discrepancies of cam latches, latch pins, and latch pin cross bolts of the MCD; replacement of all alloy steel latch pin cross bolts with corrosion-resistant steel (CRES) latch pin cross bolts of the MCD; and related investigative and corrective actions if necessary. We are issuing this AD to address the unsafe condition on these products.
Drug Products Labeled as Homeopathic; Draft Guidance for Food and Drug Administration Staff and Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for FDA staff and industry entitled ``Drug Products Labeled as Homeopathic.'' This draft guidance describes how FDA intends to prioritize enforcement and regulatory action with regard to drug products, including biological products, labeled as homeopathic and marketed in the United States without the required FDA approval.
Exchange of Coin
This final rule revises Treasury regulations relating to the exchange of uncurrent, bent, partial, fused, and mixed coins, and to update the regulations to comply with the requirement for orderly codification. The revisions include updates to redemption rates and procedures that will enhance the integrity of the acceptance and processing of bent and partial United States coins.
Notice of Availability of the Deepwater Horizon Oil Spill Louisiana Trustee Implementation Group Draft Restoration Plan and Environmental Assessment #2: Provide and Enhance Recreational Opportunities
In accordance with the Oil Pollution Act of 1990 (OPA) and the National Environmental Policy Act (NEPA), the Federal and State natural resource trustee agencies for the Louisiana Trustee Implementation Group (Louisiana TIG) have prepared a Draft Restoration Plan and Environmental Assessment #2: Provide and Enhance Recreational Opportunities (RP/EA). The Draft RP/EA describes and proposes restoration project alternatives considered by the Louisiana TIG to compensate for recreational use services lost as a result of the Deepwater Horizon oil spill. The Louisiana TIG evaluated these alternatives under criteria set forth in the OPA natural resource damage assessment (NRDA) regulations, and also evaluated the environmental consequences of the restoration alternatives in accordance with NEPA. The proposed projects are consistent with the restoration alternatives selected in the Deepwater Horizon oil spill Final Programmatic Damage Assessment and Restoration Plan/Programmatic Environmental Impact Statement (PDARP/PEIS). The purpose of this notice is to inform the public of the availability of the Draft RP/EA and to seek public comments on the document.