August 24, 2016 – Federal Register Recent Federal Regulation Documents

We, the National Marine Fisheries Service (NMFS), propose regulations under the Marine Mammal Protection Act (MMPA) to prohibit swimming with and approaching a Hawaiian spinner dolphin within 50 yards (45.7 m) (for persons, vessels, and objects), including approach by interception. These proposed regulatory measures are intended to prevent take of Hawaiian spinner dolphins from occurring in marine areas where viewing pressures are most prevalent; prohibitions would apply in waters within 2 nautical miles (nm; 3.7 km) of the Hawaiian Islands and in the waters between the islands of Lanai, Maui, and Kahoolawe. This proposed rule to establish 50-yard swim-with and approach regulations would help ensure public compliance by providing clear notice of prohibited conduct that results in take, including harassment and disturbance. Although unauthorized take of marine mammals, including harassment of spinner dolphins, already is and continues to be prohibited under the MMPA throughout their range, the purpose of this regulation is to identify and prohibit specific human activities that result in take (including harassment) of spinner dolphins, and thus reduce disturbance and disruption of important Hawaiian spinner dolphin behaviors in areas where human-dolphin interactions are most likely to occur. These proposed regulations would reduce take of Hawaiian spinner dolphins and the impact of human viewing and interaction on these animals in the Main Hawaiian Islands (MHI). We developed this proposed rule after considering comments submitted in response to an Advance Notice of Proposed Rulemaking (ANPR), as well as information received during the public scoping period for the Draft Environmental Impact Statement (DEIS), from community meetings, and from a dedicated scientific research project. Although not currently part of this proposal, we are also considering whether additional management measures may be necessary and appropriate to protect Hawaiian spinner dolphins from take, especially in essential daytime habitats that are regularly targeted by humans for dolphin-directed activities. Accordingly, we are soliciting public comment on the proposed swim-with and approach regulations, as well as alternative management options discussed in this rule and in detail in the DEIS.

EPA is proposing significant new use rules (SNURs) under the Toxic Substances Control Act (TSCA) for two chemical substances which were the subject of premanufacture notices (PMNs). This action would require persons who intend to manufacture (defined by statute to include import) or process any of the chemical substances for an activity that is designated as a significant new use by this proposed rule to notify EPA at least 90 days before commencing that activity. The required notification initiates EPA's evaluation of the intended use within the applicable review period. Manufacture and processing for the significant new use is unable to commence until EPA has conducted a review of the notice, made an appropriate determination on the notice, and taken such actions as are required in association with that determination.

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.