June 10, 2016 – Federal Register Recent Federal Regulation Documents
Results 1 - 32 of 32
Alpha-2,4,6-Tris[1-(phenyl)ethyl]-Omega-hydroxypoly(oxyethylene) poly(oxypropylene) Copolymer; Tolerance Exemption; Technical Correction
EPA issued a final rule in the Federal Register of March 2, 2016, concerning Alpha-2,4,6-Tris[1-(phenyl)ethyl]-Omega- hydroxypoly(oxyethylene) poly(oxypropylene) copolymer; Tolerance Exemption. This document corrects typographical errors.
Mandatory Deposit of Electronic Books and Sound Recordings Available Only Online
The United States Copyright Office is extending the deadline for the submission of written comments in response to its May 17, 2016 Notice of Inquiry regarding the mandatory deposit of online-only electronic books and sound recordings.
Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; Availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act.'' The guidance describes FDA's interim regulatory policy regarding the use of bulk drug substances by licensed pharmacists in State-licensed pharmacies or Federal facilities and by licensed physicians to compound human drug products while FDA develops the list of bulk drug substances that can be used in compounding under section 503A of the Federal Food, Drug, and Cosmetic Act (the FD&C Act).
Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; Availability
The Food and Drug Administration (FDA or the Agency) is announcing the availability of a guidance for industry entitled ``Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act.'' The guidance describes FDA's interim regulatory policy regarding outsourcing facilities that compound human drug products using bulk drug substances while FDA develops the list of bulk drug substances that can be used in compounding under the Federal Food, Drug, and Cosmetic Act (the FD&C Act).
Hazardous Waste Management System; Tentative Denial of Petition To Revise the RCRA Corrosivity Hazardous Characteristic
The Environmental Protection Agency (EPA or the Agency) is extending the comment period on the tentative denial of a petition to revise the Resource Conservation and Recovery Act (RCRA) corrosivity hazardous waste characteristic regulation, published in the Federal Register on April 11, 2016. EPA is tentatively denying the rulemaking petition because the materials submitted in support of the petition fail to demonstrate that the requested regulatory revisions are warranted, as further explained in the tentative denial. The Agency's review of additional materials it identified as relevant to the petition similarly did not demonstrate that any change to the corrosivity characteristic regulation is warranted at this time. The comment period is being extended to December 7, 2016.
Medical Devices; Ophthalmic Devices; Classification of Nasolacrimal Compression Device
The Food and Drug Administration (FDA) is classifying the nasolacrimal compression device into class I (general controls). The Agency is classifying the device into class I (general controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
Special Local Regulations; Harborfest Dragon Boat Race, South Haven, MI
The Coast Guard will enforce the special local regulation on the Black River in South Haven, Michigan for the Harborfest Dragonboat Race on June 18 and 19, 2016. This action is necessary and intended to ensure safety of life on navigable waters immediately prior to, during, and after the Dragonboat race. During the aforementioned period, the Coast Guard will enforce restrictions upon, and control movement of, vessels in the special regulated area.
Special Local Regulation; Cumberland River, Mile 190.0 to 191.5; Nashville, TN
The Coast Guard proposes to establish a special local regulation for all waters of the Cumberland River beginning at mile marker 190.0 and ending at mile marker 191.5 from 9 a.m. until noon on July 30, 2016. This proposed special regulation is necessary to provide safety for the participants in the ``Music City SUP Race'' marine event. This proposed rulemaking would prohibit persons and vessels from being in the special local regulated area unless authorized by the Captain of the Port Ohio Valley or a designated representative. We invite your comments on this proposed rulemaking.
Security Zone; Military Ocean Terminal Concord (MOTCO); Concord, California
The Coast Guard is revising the existing conditional security zone regulation currently in place in the navigable waters of Suisun Bay, California, near Concord, California around each of the three piers at the Military Ocean Terminal Concord (MOTCO), California (formerly United States Naval Weapons Center Concord, California). This action is intended to clarify responsibilities and authorities for enforcement of the security zone.
Special Local Regulation; On Water Activities Associated With the 2016 Macy's 4th of July Fireworks, East River, Manhattan, NY
The Coast Guard is establishing a temporary special local regulation on the navigable waters of the East River and Upper New York Bay Manhattan and Brooklyn, NY for on water vessel management associated with the Macy's 4th of July fireworks show. This Special Local Regulation allows the Coast Guard to enforce spectator vessel movement and prohibit all vessel traffic from entering the fireworks barge buffer zone during times when the associated event could pose an imminent hazard to persons and vessels operating in the area. This rule is necessary to provide for the safety of life on the navigable waters and to establish public viewing areas during the event.
Guidance Under Section 108(a) Concerning the Exclusion of Section 61(a)(12) Discharge of Indebtedness Income of a Grantor Trust or a Disregarded Entity
This document contains final regulations relating to the exclusion from gross income of discharge of indebtedness income of a grantor trust or an entity that is disregarded as an entity separate from its owner. These final regulations provide rules regarding the term ``taxpayer'' for purposes of applying the exclusion from gross income of discharge of indebtedness income of a grantor trust or a disregarded entity. These final regulations affect grantor trusts, disregarded entities, and their owners.
Drawbridge Operation Regulation; Isle of Wight (Sinepuxent) Bay, Ocean City, MD
The Coast Guard has issued a temporary deviation from the operating schedule that governs the US 50 (Harry W. Kelly Memorial) Bridge across the Isle of Wight (Sinepuxent) Bay, mile 0.5, at Ocean City, MD. The deviation is necessary to accommodate the increased vehicular traffic of the 2016 Ocean City Air Show. This deviation allows the bridge to remain in the closed-to-navigation position.
Migratory Bird Hunting; Proposed 2017-18 Migratory Game Bird Hunting Regulations (Preliminary) With Requests for Indian Tribal Proposals; Notice of Meetings
The U.S. Fish and Wildlife Service (hereinafter the Service or we) proposes to establish annual hunting regulations for certain migratory game birds for the 2017-18 hunting season. We annually prescribe outside limits (frameworks) within which States may select hunting seasons. This proposed rule provides the regulatory schedule, announces the Service Migratory Bird Regulations Committee (SRC) and Flyway Council meetings, describes the proposed regulatory alternatives for the 2017-18 duck hunting seasons, and requests proposals from Indian tribes that wish to establish special migratory game bird hunting regulations on Federal Indian reservations and ceded lands. Migratory game bird hunting seasons provide opportunities for recreation and sustenance; aid Federal, State, and tribal governments in the management of migratory game birds; and permit harvests at levels compatible with migratory game bird population status and habitat conditions.
Special Local Regulation; Midwest Masters Sprints; Maumee River; Toledo, OH
The Coast Guard is establishing a temporary special local regulation controlling movement of vessels for certain waters of the Maumee River. This action is necessary and is intended to ensure safety of life on navigable waters to be used for a rowing event immediately prior to, during, and immediately after this event. This regulation requires vessels to maintain a minimum speed for safe navigation and maneuvering.
Evidence From Statutorily Excluded Medical Sources
In accordance with section 812 of the Bipartisan Budget Act of 2015 (BBA section 812), we propose to revise our rules to explain how we would address evidence furnished by medical sources that meet one of BBA section 812's exclusionary categories (statutorily excluded medical sources). Under this proposed rule, we would not consider evidence furnished by a statutorily excluded medical source unless we find good cause to do so. We propose several circumstances in which we would find good cause, and we also propose to require statutorily excluded medical sources to notify us of their excluded status when they furnish evidence to us. These rules would allow us to fulfill obligations that we have under the Bipartisan Budget Act of 2015 (BBA).
Breast Cancer Fund, Center for Environmental Health, Center for Food Safety, Center for Science in the Public Interest, Clean Water Action, Consumer Federation of America, Earthjustice, Environmental Defense Fund, Improving Kids' Environment, Learning Disabilities Association of America, and Natural Resources Defense Council; Filing of Food Additive Petition; Correction
The Food and Drug Administration (FDA or we) is correcting a notice entitled ``Breast Cancer Fund, Center for Environmental Health, Center for Food Safety, Center for Science in the Public Interest, Clean Water Action, Consumer Federation of America, Earthjustice, Environmental Defense Fund, Improving Kids' Environment, Learning Disabilities Association of America, and Natural Resources Defense Council; Filing of Food Additive Petition'' that appeared in the Federal Register of May 20, 2016 (81 FR 31877). The document announced that Breast Cancer Fund, Center for Environmental Health, Center for Food Safety, Center for Science in the Public Interest, Clean Water Action, Consumer Federation of America, Earthjustice, Environmental Defense Fund, Improving Kids' Environment, Learning Disabilities Association of America, and Natural Resources Defense Council filed a petition proposing that we amend and/or revoke specified regulations to no longer provide for the food contact use of specified ortho- phthalates, but omitted two items. This document corrects that error.
Air Plan Approval; Illinois; NAAQS Updates
The Environmental Protection Agency (EPA) is approving revised rules submitted by the State of Illinois as State Implementation Plan (SIP) revisions. The submitted rules update Illinois' ambient air quality standards to include the 2012 primary National Ambient Air Quality Standard (NAAQS) for fine particulate matter (PM2.5), add EPA-promulgated monitoring methods, and address the ``sunset provisions'' in our regulations. In addition, the revised rules contain the timing requirements for the ``flagging of exceptional events'' and the submitting of documentation supporting the determination of exceptional events for the 2012 primary annual PM2.5 standard.
Fisheries of the Exclusive Economic Zone Off Alaska; Bycatch Management in the Bering Sea Pollock Fishery
NMFS issues this final rule to implement Amendment 110 to the Fishery Management Plan for Groundfish of the Bering Sea and Aleutian Islands management area (FMP). Amendment 110 and this final rule improve the management of Chinook and chum salmon bycatch in the Bering Sea pollock fishery by creating a comprehensive salmon bycatch avoidance program. This action is necessary to minimize Chinook and chum salmon bycatch in the Bering Sea pollock fishery to the extent practicable while maintaining the potential for the full harvest of the pollock total allowable catch (TAC) within specified prohibited species catch (PSC) limits. Amendment 110 is intended to promote the goals and objectives of the Magnuson-Stevens Fishery Conservation and Management Act, the FMP, and other applicable laws.
Air Plan Approval; Illinois; NAAQS Update
The Environmental Protection Agency (EPA) is proposing to approve revised rules submitted by the State of Illinois as State Implementation Plan (SIP) revisions. The submitted rules update Illinois' ambient air quality standards to include the 2012 primary National Ambient Air Quality Standard (NAAQS) for fine particulate matter (PM2.5), add EPA-promulgated monitoring methods, and address the ``sunset provisions'' in our regulation, finding that the 1971 NAAQS for sulfur dioxide no longer applies to the Lemont and Pekin areas in Illinois. In addition, the revised rules contain the timing requirements for the ``flagging of exceptional events'' and the submitting of documentation supporting the determination of exceptional events for the 2012 primary annual averaged PM2.5 standard.
Drawbridge Operation Regulation; Sloop Channel and Long Creek, Nassau, NY
The Coast Guard has issued a temporary deviation from the operating schedule that governs the Loop Parkway Bridge, mile 0.7, across Long Creek and the Meadowbrook State Parkway Bridge, mile 12.8, across Sloop Channel, at Nassau, New York. This temporary deviation is necessary to facilitate public safety during a public event, the Annual Salute to Veterans and Fireworks Display.
Medicare Program; Medicare Shared Savings Program; Accountable Care Organizations-Revised Benchmark Rebasing Methodology, Facilitating Transition to Performance-Based Risk, and Administrative Finality of Financial Calculations
Under the Medicare Shared Savings Program (Shared Savings Program), providers of services and suppliers that participate in an Accountable Care Organization (ACO) continue to receive traditional Medicare fee-for-service (FFS) payments under Parts A and B, but the ACO may be eligible to receive a shared savings payment if it meets specified quality and savings requirements. This final rule addresses changes to the Shared Savings Program, including: Modifications to the program's benchmarking methodology, when resetting (rebasing) the ACO's benchmark for a second or subsequent agreement period, to encourage ACOs' continued investment in care coordination and quality improvement; an alternative participation option to encourage ACOs to enter performance-based risk arrangements earlier in their participation under the program; and policies for reopening of payment determinations to make corrections after financial calculations have been performed and ACO shared savings and shared losses for a performance year have been determined.
Expatriate Health Plans, Expatriate Health Plan Issuers, and Qualified Expatriates; Excepted Benefits; Lifetime and Annual Limits; and Short-Term, Limited-Duration Insurance
This document contains proposed regulations on the rules for expatriate health plans, expatriate health plan issuers, and qualified expatriates under the Expatriate Health Coverage Clarification Act of 2014 (EHCCA). This document also includes proposed conforming amendments to certain regulations to implement the provisions of the EHCCA. Further, this document proposes standards for travel insurance and supplemental health insurance coverage to be considered excepted benefits and revisions to the definition of short-term, limited- duration insurance for purposes of the exclusion from the definition of individual health insurance coverage. These proposed regulations affect expatriates with health coverage under expatriate health plans and sponsors, issuers and administrators of expatriate health plans, individuals with and plan sponsors of travel insurance and supplemental health insurance coverage, and individuals with short-term, limited- duration insurance. In addition, this document proposes to amend a reference in the final regulations relating to prohibitions on lifetime and annual dollar limits and proposes to require that a notice be provided in connection with hospital indemnity and other fixed indemnity insurance in the group health insurance market for it to be considered excepted benefits.
Airworthiness Directives; Fokker Services B.V. Airplanes
We are superseding Airworthiness Directive (AD) 2011-17-10, for all Fokker Services B.V. Model F.28 Mark 1000, 2000, 3000, and 4000 airplanes. AD 2011-17-10 required inspecting for a by-pass wire between the housing of each in-tank fuel quantity indication (FQI) cable plug and the cable shield, and corrective actions if necessary. AD 2011-17- 10 also required revising the airplane maintenance program. This new AD removes certain airplanes from the applicability. This new AD applies only to Model F.28 Mark 1000 airplanes and also requires revising the airplane maintenance or inspection program by incorporating the instructions in revised service information. This AD was prompted by the issuance of revised service information to update the critical design configuration control limitations (CDCCLs) that address potential ignition sources inside fuel tanks. We are issuing this AD to prevent potential ignition sources inside the fuel tanks, which, in combination with flammable fuel vapors, could result in fuel tank explosions and consequent loss of the airplane.
Airworthiness Directives; Various Aircraft Equipped With BRP-Powertrain GmbH & Co KG 912 A Series Engine
We are adopting a new airworthiness directive (AD) for various aircraft equipped with a BRP-Powertrain GmbH & Co KG (formerly Rotax Aircraft Engines) 912 A series engine. This AD results from mandatory continuing airworthiness information (MCAI) issued by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as a design change of the engine cylinder head temperature sensor without a concurrent revision of the engine model designation, the engine part number, or the cockpit indication to the pilot. We are issuing this AD to require actions to address the unsafe condition on these products.
National Highway-Rail Crossing Inventory Reporting Requirements
This document responds to a petition for reconsideration of FRA's January 6, 2015, final rule addressing U.S. DOT National Highway- Rail Crossing Inventory (Crossing Inventory or Inventory) Reporting Requirements. This document amends and clarifies the final rule in response to the petition for reconsideration and makes certain additional amendments to the rule to address practical implementation problems that arose after publication of the final rule.
Airworthiness Directives; PILATUS AIRCRAFT LTD. Airplanes
We are adopting a new airworthiness directive (AD) for PILATUS AIRCRAFT LTD. Models PC-12, PC-12/45, PC-12/47, and PC-12/47E airplanes. This AD results from mandatory continuing airworthiness information (MCAI) issued by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as incorrect installation instructions of the torlon plates in the airplane maintenance manual resulting in the incorrect installation of the torlon plates in the forward wing-to-fuselage attachment. We are issuing this AD to require actions to address the unsafe condition on these products.
Airworthiness Directives; B/E Aerospace Protective Breathing Equipment Part Number 119003-11
We are adopting a new airworthiness directive (AD) for certain B/E Aerospace protective breathing equipment (PBE) that is installed on airplanes. This AD was prompted by a report of a PBE catching fire upon activation by a crewmember. This AD requires replacing the PBE. We are issuing this AD to correct the unsafe condition on these products.
Control of Alcohol and Drug Use: Coverage of Maintenance of Way (MOW) Employees and Retrospective Regulatory Review-Based Amendments
In response to Congress' mandate in the Rail Safety Improvement Act of 2008 (RSIA), FRA is expanding the scope of its drug and alcohol regulation to cover MOW employees. This rule also codifies guidance from FRA compliance manuals, responds to National Transportation Safety Board (NTSB) recommendations, and adopts substantive amendments based upon FRA's regulatory review of 30 years of implementation of this part. The final rule contains two significant differences from FRA's July 28, 2014 Notice of Proposed Rulemaking (NPRM). First, it adopts part 214's definition of ``roadway worker'' to define ``MOW employee'' under this part. Second, because FRA has withdrawn its proposed peer support requirements, subpart K contains a revised version of the troubled employee identification requirements previously in subpart E.
Railroad Workplace Safety; Roadway Worker Protection Miscellaneous Revisions (RRR)
FRA is amending its Roadway Worker Protection (RWP) regulation to resolve interpretative issues that have arisen since the 1996 promulgation of that rule. In particular, this final rule adopts certain terms, resolves miscellaneous interpretive issues, codifies certain FRA Technical Bulletins, adopts new requirements governing redundant signal protections and the movement of roadway maintenance machinery over signalized non-controlled track, and amends certain qualification requirements for roadway workers. This final rule also deletes three outdated incorporations by reference of industry standards in FRA's Bridge Worker Safety Standards, and cross references the Occupational Safety and Health Administration's (OSHA) regulations on the same point.
Airworthiness Directives; Airbus Airplanes
We are superseding Airworthiness Directive (AD) 99-16-01 for certain Airbus Model A300 B4-600, B4-600R, and F4-600R series airplanes, and Model A300 C4-605R Variant F airplanes (collectively called Model A300-600 series airplanes). AD 99-16-01 required repetitive inspections of certain bolt holes where parts of the main landing gear (MLG) are attached to the wing rear spar, and repair if necessary. Since we issued AD 99-16-01, we have determined that the risk of cracking in the wing rear spar is higher than initially determined. This new AD adds airplanes to the applicability, reduces the compliance times and repetitive intervals for the inspections, and changes the inspection procedures. This AD was prompted by a determination that the risk of cracking in the wing rear spar is higher than initially determined. We are issuing this AD to detect and correct cracking of the rear spar of the wing, which could result in reduced structural integrity of the airplane.
Incentive-Based Compensation Arrangements
The OCC, Board, FDIC, FHFA, NCUA, and SEC (the Agencies) are seeking comment on a joint proposed rule (the proposed rule) to revise the proposed rule the Agencies published in the Federal Register on April 14, 2011, and to implement section 956 of the Dodd-Frank Wall Street Reform and Consumer Protection Act (Dodd-Frank Act). Section 956 generally requires that the Agencies jointly issue regulations or guidelines: (1) Prohibiting incentive-based payment arrangements that the Agencies determine encourage inappropriate risks by certain financial institutions by providing excessive compensation or that could lead to material financial loss; and (2) requiring those financial institutions to disclose information concerning incentive- based compensation arrangements to the appropriate Federal regulator.
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