November 7, 2017 – Federal Register Recent Federal Regulation Documents
Results 1 - 18 of 18
Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic; Coastal Migratory Pelagic Resources of the Gulf of Mexico and Atlantic Region; Commercial Closure for Spanish Mackerel
NMFS implements an accountability measure (AM) for commercial Spanish mackerel in the northern zone of the Atlantic exclusive economic zone (EEZ) through this temporary rule. NMFS has determined that the revised commercial quota for Spanish mackerel in the northern zone of the Atlantic EEZ will be reached by November 7, 2017. Therefore, NMFS closes the northern zone of the Atlantic EEZ to commercial harvest of Spanish mackerel on November 7, 2017. This closure is necessary to protect the Spanish mackerel resource in the Atlantic.
Fisheries of the Northeastern United States; Scup Fishery; 2018 and Projected 2019 Specifications
NMFS proposes revised scup specifications for the 2018 fishing year and projected specifications for 2019. Updated scientific information regarding the scup stock indicates that higher catch limits may be implemented to achieve optimum yield. This action is intended to inform the public of the proposed specifications for the 2018 fishing year and projected specifications for 2019.
Importation, Interstate Movement, and Environmental Release of Certain Genetically Engineered Organisms
We are withdrawing a proposed rule that would have revised our regulations regarding the importation, interstate movement, and environmental release of certain genetically engineered organisms. We are taking this action after considering the comments we received following the publication of the proposed rule.
Listing of Color Additives Exempt From Certification; Calcium Carbonate
The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the safe use of calcium carbonate to color hard and soft candy, mints, and chewing gum. We are taking this action in response to a color additive petition submitted by the Wm. Wrigley Jr. Company.
General Hospital and Personal Use Devices; Reclassification of Sharps Needle Destruction Device
The Food and Drug Administration (FDA) is issuing this proposed order to reclassify the needle destruction device, renaming the device to ``sharps needle destruction device,'' a postamendments class III device (regulated under product code MTV), into class II (special controls), subject to premarket notification. FDA is also identifying the proposed special controls that the Agency believes are necessary to provide a reasonable assurance of safety and effectiveness of the device. FDA is proposing this reclassification on its own initiative based on new information. If finalized, this order will reclassify these types of devices from class III to class II and reduce regulatory burdens on industry as these types of devices will no longer be required to submit a premarket approval application (PMA) but can instead submit a less burdensome premarket notification (510(k)) before marketing their device.
Rule on Attorney-Client Privilege for Trials Before the Patent Trial and Appeal Board
This final rule on attorney-client privilege amends the existing rules relating to the United States Patent and Trademark Office (Office or USPTO) trial practice for inter partes review, post- grant review, the transitional program for covered business method patents, and derivation proceedings that implemented provisions of the Leahy-Smith America Invents Act (``AIA'') providing for trials before the Office.
Medical Devices; Exemption From Premarket Notification; Class II Devices; Autosomal Recessive Carrier Screening Gene Mutation Detection System
The Food and Drug Administration (FDA or Agency) is publishing an order to exempt autosomal recessive carrier screening gene mutation detection systems from the premarket notification requirements, subject to certain limitations. This exemption from 510(k), subject to certain limitations, is immediately in effect for autosomal recessive carrier screening gene mutation detection systems. This exemption will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with certain Federal regulations. FDA is also amending the codified language for the autosomal recessive carrier screening gene mutation detection system devices classification regulation to reflect this final determination.
Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Total 25-Hydroxyvitamin D Mass Spectrometry Test System
The Food and Drug Administration (FDA, the Agency, or we) is classifying the total 25-hydroxyvitamin D mass spectrometry test system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the total 25-hydroxyvitamin D mass spectrometry test system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Medical Devices; Immunology and Microbiology Devices; Classification of the Genetic Health Risk Assessment System
The Food and Drug Administration (FDA, the Agency, or we) is classifying the genetic health risk assessment system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the genetic health risk assessment system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Airworthiness Directives; Rolls-Royce plc Turbofan Engines
We are adopting a new airworthiness directive (AD) for all Rolls-Royce plc (RR) RB211-Trent 970-84 and RB211-Trent 972-84 turbofan engines. This AD requires an inspection of the drains mast. This AD was prompted by cracks found in the transition duct area of the drains mast. We are issuing this AD to address the unsafe condition on these products.
Fisheries of the Northeastern United States; Golden Tilefish Fishery; 2018 and Projected 2019-2020 Specifications
NMFS issues final specifications for the 2018 commercial golden tilefish fishery and projected specifications for 2019 and 2020. This action establishes allowable harvest levels and other management measures to prevent overfishing while allowing optimum yield, consistent with the Magnuson-Stevens Fishery Conservation and Management Act and the Tilefish Fishery Management Plan. It is also intended to inform the public of these specifications for the 2018 fishing year and projected specifications for 2019-2020.
Airworthiness Directives; IPECO Pilot and Co-Pilot Seats
We are adopting a new airworthiness directive (AD) for certain Ipeco Holdings Ltd. (Ipeco) pilot and co-pilot seats. This AD requires modification and reidentification of the affected seats. This AD was prompted by reports of unexpected movement of pilot and co-pilot seats on takeoff and landing. We are issuing this AD to address the unsafe condition on these products.
Airworthiness Criteria: Glider Design Criteria for Alexander Schleicher GmbH & Co. Models ASG 32 & ASG 32 Mi Gliders
These airworthiness design criteria for the Alexander Schleicher GmbH & Co. models ASG 32 & ASG 32 Mi gliders. The administrator finds the design criteria, which make up the certification basis for the ASG 32 & ASG 32 Mi gliders, acceptable.
Airworthiness Directives; Piper Aircraft, Inc. Airplanes
We propose to adopt a new airworthiness directive (AD) for certain Piper Aircraft, Inc. Models PA-28-140, PA-28-150, PA-28-160, PA-28-180, PA-28-235, PA-32-260, and PA-32-300 airplanes. This proposed AD was prompted by reports of corrosion found in an area of the main wing spar not easily accessible for inspection. This proposed AD would require installing an inspection access panel in the lower wing skin near the left and the right main wing spars if not already there, inspecting the left and the right main wing spars for corrosion, and taking all necessary corrective actions. We are proposing this AD to address the unsafe condition on these products.
Determination of Rates and Terms for Public Broadcasting (PB III)
The Copyright Royalty Judges solicit comments on proposed rates and terms for use of certain works in connection with noncommercial broadcasting for the period commencing January 1, 2018, and ending on December 31, 2022.
Medicare and Medicaid Programs; CY 2018 Home Health Prospective Payment System Rate Update and CY 2019 Case-Mix Adjustment Methodology Refinements; Home Health Value-Based Purchasing Model; and Home Health Quality Reporting Requirements
This final rule updates the home health prospective payment system (HH PPS) payment rates, including the national, standardized 60- day episode payment rates, the national per-visit rates, and the non- routine medical supply (NRS) conversion factor, effective for home health episodes of care ending on or after January 1, 2018. This rule also: Updates the HH PPS case-mix weights using the most current, complete data available at the time of rulemaking; implements the third year of a 3-year phase-in of a reduction to the national, standardized 60-day episode payment to account for estimated case-mix growth unrelated to increases in patient acuity (that is, nominal case-mix growth) between calendar year (CY) 2012 and CY 2014; and discusses our efforts to monitor the potential impacts of the rebasing adjustments that were implemented in CY 2014 through CY 2017. In addition, this rule finalizes changes to the Home Health Value-Based Purchasing (HHVBP) Model and to the Home Health Quality Reporting Program (HH QRP). We are not finalizing the implementation of the Home Health Groupings Model (HHGM) in this final rule.
Air Plan Approval; Wisconsin; 2017 Revisions to NR 400 and 406
The Environmental Protection Agency (EPA) is proposing to approve a revision to the Wisconsin State Implementation Plan (SIP) submitted by the Wisconsin Department of Natural Resources (WDNR) to EPA on May 16, 2017. The revision replaces the definition of ``emergency electric generator'' with a broader definition of ``restricted internal combustion engine''. In addition, the revision makes amendments to procedures for revoking construction permits as well as language changes and other administrative updates. Lastly, WDNR is withdrawing two Wisconsin Administrative Code provisions that affect eligibility under general and construction permits. WDNR requested these changes to align state and Federal requirements and ensure consistency. EPA is proposing approval of Wisconsin's May 16, 2017, request because the Agency has made the preliminary determination that this SIP revision is consistent with the Clean Air Act and applicable EPA regulations regarding PSD.
Air Plan Approval; Wisconsin; 2017 Revisions to NR 400 and 406
The Environmental Protection Agency (EPA) is taking direct final action to approve a revision to the Wisconsin State Implementation Plan (SIP) submitted by the Wisconsin Department of Natural Resources (WDNR) to EPA on May 16, 2017. The revision replaces the definition of ``emergency electric generator'' with a broader definition of ``restricted internal combustion engine''. In addition, the revision makes amendments to procedures for revoking construction permits as well as language changes and other administrative updates. Lastly, WDNR is removing from the SIP two Wisconsin Administrative Code provisions that affect eligibility of coverage under general and construction permits.
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