2016 – Federal Register Recent Federal Regulation Documents

This amendment adopts miscellaneous amendments to the required IFR (instrument flight rules) altitudes and changeover points for certain Federal airways, jet routes, or direct routes for which a minimum or maximum en route authorized IFR altitude is prescribed. This regulatory action is needed because of changes occurring in the National Airspace System. These changes are designed to provide for the safe and efficient use of the navigable airspace under instrument conditions in the affected areas.

The Coast Guard has issued a temporary deviation from the operating schedule that governs the Rock Island Railroad and Highway Drawbridge across the Upper Mississippi River, mile 482.9, at Rock Island, Illinois. The deviation is necessary to facilitate a charity marathon race. This deviation allows the bridge to be maintained in the closed-to-navigation position for four and a half hours.

The Coast Guard has issued a temporary deviation from the operating schedule that governs the U.S. 70/Alfred A. Cunningham Bridge across the Trent River, mile 0.0, at New Bern, NC. The deviation is necessary to facilitate safe participation in the Multiple Sclerosis Society's Historic New Bern Bike Ride. This deviation allows the bridge to remain in the closed-to-navigation position.

The Food and Drug Administration (FDA, we, or Agency) is announcing the availability of a draft guidance for industry entitled ``Hazard Analysis and Risk-Based Preventive Controls for Human Food: Guidance for Industry.'' This draft guidance document includes several chapters of a multi-chapter guidance intended to explain our current thinking on how to comply with the requirements for hazard analysis and risk-based preventive controls under our rule entitled ``Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food.''

The U.S. Office of Personnel Management (OPM) is issuing a proposed rule to redefine the geographic boundaries of the Asheville, NC, and Charlotte, NC, appropriated fund Federal Wage System (FWS) wage areas. The final rule will redefine Alexander and Catawba Counties, NC, from the Charlotte wage area to the Asheville wage area. These changes are based on a consensus recommendation of the Federal Prevailing Rate Advisory Committee (FPRAC) to best match the counties proposed for redefinition to a nearby FWS survey area.

The Food and Drug Administration (FDA, the Agency, we) proposes to amend the animal drug regulations by revising the definitions of the two categories of new animal drugs used in medicated feeds to base category assignment only on approved uses in major animal species. The proposed revision will preserve the availability of medicated feeds intended for therapeutic use in minor animal species and prevent a significant disincentive for future development of additional minor species therapies.

The U.S. Environmental Protection Agency (EPA) proposes to revise its regulations to streamline and clarify processes related to submission and review of title V petitions. This notice covers five key areas, each of which should increase stakeholder access to and understanding of the petition process and aid the EPA's review of petitions. First, the EPA is proposing regulatory provisions that provide direction as to how petitions should be submitted to the agency. Second, the EPA is proposing regulatory provisions that describe the expected format and minimum required content for title V petitions. Third, the proposal clarifies that permitting authorities are required to respond to significant comments received during the public comment period for draft title V permits, and to provide that response with the proposed title V permit to the EPA for the agency's 45-day review period. Fourth, guidance is provided in the form of ``recommended practices'' for various stakeholders to help ensure title V permits have complete administrative records and comport with the requirements of the Clean Air Act (CAA or Act). Fifth, to increase familiarity with the post-petition process, this notice presents information on the agency's interpretation of certain title V provisions of the CAA and its implementing regulations regarding the steps following an EPA objection in response to a title V petition, as previously discussed in specific title V orders.

The U.S. Department of Energy (``DOE'') is granting in part and denying in part a series of petitions to amend a recently published rule that established a procedure through which a party can, within a prescribed period after DOE posts a rule establishing or amending an energy conservation standard, identify a possible error in such a rule and request that DOE correct the error before the rule is published in the Federal Register (``error correction rule''). DOE also provided an opportunity for the public to comment on these petitions. This document responds to both the petitions and related comments that were submitted and received in accordance with the timelines established in a prior Federal Register notice inviting such petitions and comments.

The Food and Drug Administration (FDA) is proposing to amend the regulations for good laboratory practice (GLP) for nonclinical laboratory studies to require a complete quality system approach, referred to as a GLP Quality System, when safety and toxicity studies support or are intended to support applications or submissions for products regulated by FDA. We are proposing additional management responsibilities and standard operating procedures (SOPs) consistent with the proposed requirement for a GLP Quality System. We also propose to revise the testing facility definition to reflect current practices for the conduct of nonclinical laboratory studies, particularly multisite studies. These proposals are intended to build quality into planning, conducting, and reporting a nonclinical laboratory study and to help ensure data quality and integrity.

In this document, the Federal Communications Commission (Commission or FCC) seeks comment on proposed service rules to allow flexible fixed and mobile uses in additional bands and on refinements to the rules the Commission adopted in FCC 16-89. These refinements include: Providing additional detail on the sharing arrangement the Commission adopted in FCC 16-89 for the 37 GHz band; performance requirements for innovative uses such as Internet of Things (IoT) and machine-to-machine communications; additional issues relating to our mobile spectrum holdings policies; whether antenna height limits are necessary in mmW bands; whether minimum bandwidth scaling factors are necessary for transmitter power limits; whether allowing higher Power Flux Density (PFD) levels for Fixed Satellite Service (FSS) in the 37 and 39 GHz bands would be consistent with terrestrial use of those bands; refining the coordination limits for point-to-point operations; and on sharing analysis and modeling.

The U.S. Department of Energy (DOE) proposes to revise its test procedures for central air conditioners and heat pumps (CAC/HP) established under the Energy Policy and Conservation Act. DOE published several proposals in a November 2015 supplemental notice of proposed rulemaking (SNOPR). DOE finalized some of the proposed test procedure amendments in a June 2016 final rule. This SNOPR proposes additional revisions to some of the amendments proposed in the past notices and proposes some additional amendments. Specifically, this SNOPR proposes two sets of amendments to the test procedure: Amendments to appendix M that would be required as the basis for making efficiency representations starting 180 days after final rule publication; and amendments as part of a new appendix M1 that would be the basis for making efficiency representations as of the compliance date for any amended energy conservation standards. Broadly speaking, the proposed amendments address the off-mode test procedures, clarifications on test set-up and fan delays, limits to gross indoor fin surface area for valid combinations, external static pressure conditions for testing, clarifications on represented values for CAC/HP that are distributed in commerce with multiple refrigerants, and the methodology for testing and calculating heating performance. DOE does not expect the proposed changes to appendix M to change measured efficiency. However, DOE has determined that the proposed procedures in new appendix M1 would change measured efficiency. DOE welcomes comments from the public on any subject within the scope of this test procedure rulemaking.

The Employment and Training Administration (ETA) of the U.S. Department of Labor (Department) issues this final rule to implement statutory amendments to the Extended Benefits (EB) program, which pays extra weeks of unemployment compensation during periods of high unemployment in a State. Specifically, this final rule codifies a methodology for computing the Total Unemployment Rate (TUR) indicator which is an optional indicator used to measure unemployment in a State. Also, the final rule makes technical corrections to the current regulations and corrects minor mistakes.

This final rule amends the Export Administration Regulations (EAR) by adding ten persons under fourteen entries to the Entity List. The ten persons who are added to the Entity List have been determined by the U.S. Government to be acting contrary to the national security or foreign policy interests of the United States. These ten persons will be listed on the Entity List under the destinations of Iraq, the Philippines, Syria, and Turkey.

In this action, the Environmental Protection Agency (EPA) is determining that 60 days is insufficient time to complete the technical and other analyses and public notice-and-comment process required for our review of a petition submitted by the state of Delaware pursuant to section 126 of the Clean Air Act (CAA). The petition requests that the EPA make a finding that the Brunner Island Steam Electric Station located in York County, Pennsylvania, emit air pollution that significantly contributes to nonattainment and interferes with maintenance of the 2008 and 2015 ozone national ambient air quality standards (NAAQS) in state of Delaware. Under section 307(d)(10) of CAA, the EPA is authorized to grant a time extension for responding to a petition if the EPA determines that the extension is necessary to afford the public, and the agency, adequate opportunity to carry out the purposes of the section 307(d)'s notice-and-comment rulemaking requirements. By this action, the EPA is making that determination. The EPA is therefore extending the deadline for acting on the petition to no later than March 5, 2017.

The Coast Guard proposes to establish a temporary safety zone for navigable waters of the Columbia River within a 500-yard radius of the small boat ``Nessy,'' while in the area of Sand Island, near Chinook, WA, and all involved associated vessels in support of Double- Crested Cormorant removal operations conducted by the U.S. Army Corps of Engineers and U.S. Department of Agriculture Wildlife Services. This proposed rulemaking would prohibit persons and vessels from being in the safety zone unless authorized by the Captain of the Port Columbia River, or a designated representative. We invite your comments on this proposed rulemaking.

The Environmental Protection Agency (EPA) is proposing to approve a State Implementation Plan (SIP) revision, submitted by the State of Florida through the Florida Department of Environmental Protection (FL DEP), to EPA on April 3, 2015, for the purpose of providing for attainment of the 2010 Sulfur Dioxide (SO2) National Ambient Air Quality Standards (NAAQS) in the Hillsborough County SO2 nonattainment area (hereafter referred to as the ``Hillsborough Area'' or ``Area''). The Hillsborough Area is comprised of a portion of Hillsborough County in Florida surrounding the Mosaic Fertilizer, LLC Riverview plant (hereafter referred to as ``Mosaic''). The attainment plan includes the base year emissions inventory, an analysis of the reasonably available control technology (RACT) and reasonably available control measures (RACM) requirements, a reasonable further progress (RFP) plan, a modeling demonstration of SO2 attainment, and contingency measures for the Hillsborough Area. As a part of approving the attainment demonstration, EPA is also proposing to approve into the Florida SIP the SO2 emissions limits and associated compliance parameters. This action is being taken in accordance with Clean Air Act (CAA or Act) and EPA's guidance related to SO2 attainment planning.

NMFS is opening directed fishing for Pacific cod by catcher vessels less than 60 feet (18.3 meters) length overall (LOA) using hook-and-line or pot gear in the Bering Sea and Aleutian Islands Management Area (BSAI). This action is necessary to fully use the 2016 total allowable catch of Pacific cod allocated to catcher vessels less than 60 feet LOA using hook-and-line or pot gear in the BSAI.

This proposed rule would amend the Beef Promotion and Research Order (Order) established under the Beef Promotion and Research Act of 1985 (Act) to add six Harmonized Tariff System (HTS) codes for imported veal and veal products and update assessment levels for imported veal and veal products based on revised determinations of live animal equivalencies.

The U.S. Nuclear Regulatory Commission (NRC) is proposing to amend its spent fuel storage regulations by revising the ``List of Approved Spent Fuel Storage Casks'' to add Amendment No. 2 to the Certificate of Compliance (CoC) No. 1032 for the Holtec International (Holtec) HI-STORM Flood/Wind (FW) Multipurpose Canister (MPC) Storage. Amendment No. 2 adds new fuel types to the HI-STORM FW MPC Storage System, includes new criticality calculations, updates an existing fuel type description, and includes changes previously incorporated in Amendment No. 0 to CoC No. 1032, Revision 1, and revises CoC Condition No. 8 to provide additional clarity and guidance.

This document contains corrections to final regulations (TD 9777) that were published in the Federal Register on Monday, July 18, 2016 (81 FR 46582). The final regulations relate to the arbitrage restrictions under section 148 of the Internal Revenue Code applicable to tax-exempt bonds and other tax-advantaged bonds issued by State and local governments.

The Coast Guard is establishing a temporary safety zone on the Upper Mississippi River from mile 180 to mile 180.5. This temporary safety zone is necessary to protect persons and property from potential damage and safety hazards during a fireworks display on and over the navigable waterway. During the period of enforcement, entry into the safety zone is prohibited unless specifically authorized by the Captain of the Port Upper Mississippi River (COTP) or other designated representative.

This document amends the U.S. Customs and Border Protection (``CBP'') regulations to update the provisions relating to the prohibition on importation of jadeite or rubies mined or extracted from Burma, and articles of jewelry containing jadeite or rubies mined or extracted from Burma, following the expiration of the Burmese Freedom and Democracy Act of 2003, as amended by the Tom Lantos Block Burmese JADE (Junta's Anti-Democratic Efforts) Act of 2008. The CBP regulations are amended to reflect the import prohibitions set forth in Executive Order 13651 of August 6, 2013.

This request for information seeks public comment regarding concerns about health care providers and provider-affiliated organizations steering people eligible for or receiving Medicare and/or Medicaid benefits to an individual market plan for the purpose of obtaining higher payment rates. CMS is concerned about reports of this practice and is requesting comments on the frequency and impact of this issue from the public. We believe this practice not only could raise overall health system costs, but could potentially be harmful to patient care and service coordination because of changes to provider networks and drug formularies, result in higher out-of-pocket costs for enrollees, and have a negative impact on the individual market single risk pool (or the combined risk pool in states that have chosen to merge their risk pools). We are seeking input from stakeholders and the public regarding the frequency and impact of this practice, and options to limit this practice.

The Environmental Protection Agency (EPA) is approving, as a revision to the Indiana State Implementation Plan (SIP), a submittal by the Indiana Department of Environmental Management (IDEM) dated July 17, 2015. The submittal contains a new volatile organic compound (VOC) limit for antifoulant coatings used in shipbuilding and ship repair facilities located in Clark, Floyd, Lake, and Porter counties. The submittal also includes a demonstration that this revision satisfies the anti-backsliding provisions of the Clean Air Act (CAA). The submittal additionally removes obsolete dates and clarifies a citation.

The Environmental Protection Agency (EPA) is proposing to approve an Early Progress Plan and motor vehicle emissions budgets (MVEBs) for volatile organic compounds and oxides of nitrogen for Kenosha County, Wisconsin. Wisconsin submitted an Early Progress Plan for Kenosha County on January 16, 2015. This submittal was developed to establish MVEBs for the Kenosha 8-hour ozone nonattainment area. This approval of the Early Progress Plan for the Kenosha 2008 8-Hour ozone nonattainment area is based on EPA's determination that Wisconsin has demonstrated that the State Implementation Plan (SIP) revision containing these MVEBs, when considered with the emissions from all sources, shows some progress toward attainment from the 2011 base year through a 2015 target year.