August 2016 – Federal Register Recent Federal Regulation Documents

The Health Resources and Services Administration (HRSA) implements section 340B of the Public Health Service Act (PHSA), which is referred to as the ``340B Drug Pricing Program'' or the ``340B Program.'' This proposed rule will apply to all drug manufacturers and covered entities that participate in the 340B Program. The proposed rule sets forth the requirements and procedures for the 340B Program's administrative dispute resolution process.

The Environmental Protection Agency (EPA) is finalizing a limited approval and limited disapproval of a demonstration of creditable emission reductions submitted by California for approval into the San Joaquin Valley (SJV) portion of the California State Implementation Plan (SIP). This SIP submittal demonstrates that certain state incentive funding programs have achieved specified amounts of reductions in emissions of nitrogen oxides (NOX) and fine particulate matter (PM2.5) in the SJV area by 2014. The effect of this action would be to approve specific amounts of emission reductions for credit toward an emission reduction commitment in the California SIP. We are approving these emission reductions under the Clean Air Act (CAA or the Act).

The Environmental Protection Agency (EPA) is taking final action to approve and conditionally approve revisions to the State of California's State Implementation Plan (SIP) for the San Joaquin Valley (SJV) area. The revisions consist of an update to the Motor Vehicle Emissions Budgets (``budgets'') for nitrogen oxides (NOX) and volatile organic compounds (VOCs) for the 1997 8-hour ozone national ambient air quality standard (NAAQS or ``standard'') for the SJV ozone nonattainment area and for NOX and coarse particulate matter (PM10) for the 1987 24-hour PM10 standard for the SJV PM10 maintenance area. The EPA is approving the SJV ozone revised budgets and conditionally approving the PM10 budgets in accordance with the requirements of the Clean Air Act (CAA or ``Act'') and the EPA's regulations.

The Environmental Protection Agency (EPA) is proposing to approve State Implementation Plan (SIP) revisions submitted by the State of Wyoming on May 28, 2015 and November 6, 2015. The amendments update the version of the Code of Federal Regulations (CFR) incorporated by reference into the rules of the State of Wyoming for Chapter 2, Section 12; Chapter 3, General Emission Standards, Section 9; and Chapter 6, Prevention of Significant Deterioration, Section 4. The May 28, 2015 submittal updates a citation to a Federal Register article (i.e., Federal Register notice) under the definition of ``tpy CO2 equivalent emissions (CO2e),'' and lists a new minor source baseline date for fine particulate. The State also proposes to update the primary air quality standards for particulate matter (PM2.5) to reflect federal updates that went into effect in January 2013. The updated primary PM2.5 standard is 12 micrograms per cubic meter ([micro]g/m\3\) annual arithmetic mean concentration, which is lowered from its previous level of 15 [micro]g/ m\3\. The EPA is also proposing approval of portions of the State's February 6, 2014 2008 ozone National Ambient Air Quality Standards (NAAQS) infrastructure certification regarding prevention of significant deterioration (PSD) and the good neighbor provision. The EPA is not taking action on the Chapter 6, Permitting Requirements, Section 14 portion of the May 24, 2012 submittal because it has been superseded by a November 6, 2015 submittal (81 FR 35271). The EPA is not taking action on a May 24, 2012 submittal or a March 8, 2013 submittal because they have been superseded by the May 28, 2015 submittal.

We, the U.S. Fish and Wildlife Service (Service), are removing the San Miguel Island fox (Urocyon littoralis littoralis), Santa Rosa Island fox (U. l. santarosae), and Santa Cruz Island fox (U. l. santacruzae) from the Federal List of Endangered and Threatened Wildlife and are reclassifying the Santa Catalina Island fox (U. l. catalinae) from an endangered species to a threatened species. This action is based on a thorough review of the best available scientific and commercial information, which indicates that the threats to the San Miguel Island fox, Santa Rosa Island fox, and Santa Cruz Island fox have been eliminated or reduced to the point that each of the subspecies no longer meets the definition of an endangered species or a threatened species under the Endangered Species Act of 1973, as amended (Act), and that the threats to the Santa Catalina Island fox have been reduced to the point that the subspecies can be reclassified as a threatened species. We also announce the availability of a final post- delisting monitoring plan for the San Miguel Island fox, Santa Rosa Island fox, and Santa Cruz Island fox.

The Department of Veterans Affairs (VA) proposes to amend the portion of the VA Schedule for Rating Disabilities (VASRD or Rating Schedule) that addresses skin conditions. The purpose of these changes is to incorporate medical advances that have occurred since the last review, update current medical terminology, and provide clear evaluation criteria. The proposed rule reflects advances in medical knowledge, recommendations from the Skin Disorders Work Group, which is comprised of subject matter experts from both the Veterans Benefits Administration and the Veterans Health Administration, and comments from experts and the public gathered as part of a public forum. The public forum, focusing on revisions to the skin conditions section of the VASRD, was held in January 2012.

We are adopting a new airworthiness directive (AD) for all Airbus Model A318, A319, A320, and A321 series airplanes. This AD was prompted by reports of premature aging of certain passenger chemical oxygen generators that resulted in the generators failing to activate. This AD requires an inspection to determine if certain passenger chemical oxygen generators are installed and replacement of affected passenger chemical oxygen generators. We are issuing this AD to prevent failure of the passenger chemical oxygen generator to activate and consequently not deliver oxygen during an emergency, possibly resulting in injury to the airplane occupants.

To facilitate research involving marijuana and its chemical constituents, DEA is adopting a new policy that is designed to increase the number of entities registered under the Controlled Substances Act (CSA) to grow (manufacture) marijuana to supply legitimate researchers in the United States. This policy statement explains how DEA will evaluate applications for such registration consistent with the CSA and the obligations of the United States under the applicable international drug control treaty.

The Securities and Exchange Commission (``SEC'' or ``Commission'') is adopting certain amendments to Regulation SBSR Reporting and Dissemination of Security-Based Swap Information (``Regulation SBSR''). Specifically, new Rule 901(a)(1) of Regulation SBSR requires a platform (i.e., a national securities exchange or security-based swap execution facility (``SB SEF'') that is registered with the Commission or exempt from registration) to report a security- based swap executed on such platform that will be submitted to clearing. New Rule 901(a)(2)(i) of Regulation SBSR requires a registered clearing agency to report any security-based swap to which it is a counterparty. The Commission is adopting certain conforming amendments to other provisions of Regulation SBSR in light of the newly adopted amendments to Rule 901(a), and an amendment that would require registered security-based swap data repositories (``SDRs'') to provide the security-based swap transaction data that they are required to publicly disseminate to the users of the information on a non-fee basis. The Commission also is adopting amendments to Rule 908(a) to extend Regulation SBSR's regulatory reporting and public dissemination requirements to additional types of cross-border security-based swaps. The Commission is offering guidance regarding the application of Regulation SBSR to prime brokerage transactions and to the allocation of cleared security-based swaps. Finally, the Commission is adopting a new compliance schedule for the portions of Regulation SBSR for which the Commission has not previously specified compliance dates.

This final rule revises HUD's property disposition regulations. Specifically, this rule consolidates and reorganizes these regulations to better reflect industry standards, and allow HUD to conduct its Single Family Property Disposition Program more efficiently and effectively so that HUD can obtain the greatest value for its real estate-owned (REO) properties in different market conditions. This final rule follows publication of the October 2, 2015, proposed rule and, after considering public comments submitted in response to the proposed rule, adopts the proposed rule with minor change.

This regulation establishes tolerances for residues of halauxifen-methyl and its metabolite, XDE-729 acid, in or on multiple commodities which are identified and discussed later in this document. Dow AgroSciences LLC requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

This document corrects technical and typographical errors that appeared in the final rule published in the March 8, 2016 Federal Register (81 FR 12204 through 12352) entitled ``Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2017.'' The effective date for the rule was May 9, 2016.

The Environmental Protection Agency (EPA) is taking direct final action to make a technical correction to an equation in an appendix in the National Ambient Air Quality Standards (NAAQS) for Particle Pollution. Equation 2 describes an intermediate step in the calculation of the design value for the annual PM2.5 (particles with an aerodynamic diameter less than or equal to a nominal 2.5 micrometers) NAAQS. This action corrects a scrivener's error in one of the equations used to calculate an annual mean PM2.5 concentration, to properly account for cases where a site does not have four complete quarters of data and passes one of two substitution tests. This change accurately reflects the intended calculation of the annual mean PM2.5 design value and is consistent with the text elsewhere in the appendix.

NMFS proposes regulations to implement Regulatory Amendment 16 to the Fishery Management Plan for the Snapper-Grouper Fishery of the South Atlantic Region (FMP) (Regulatory Amendment 16), as prepared and submitted by the South Atlantic Fishery Management Council (Council). If implemented, this proposed rule would revise the current seasonal prohibition on the use of black sea bass pot gear in the South Atlantic and add additional gear marking requirements for black sea bass pot gear. The purpose of this proposed rule is to reduce the adverse socioeconomic impacts from the current seasonal black sea bass pot gear prohibition while continuing to protect Endangered Species Act (ESA) listed whales in the South Atlantic. This proposed rule would also help better identify black sea bass pot gear in the South Atlantic.

The Federal Transit Administration is issuing a final rule to establish substantive and procedural rules for FTA's administration of a comprehensive safety program to improve the safety of the Nation's public transportation systems. This final rule provides the framework for FTA to monitor, oversee and enforce transit safety, based on the methods and principles of Safety Management Systems.

The Food and Drug Administration (FDA, the Agency, or we) is making technical corrections to its regulations for hearing procedures for denial of approval or withdrawal of approval of new animal drug applications. The Agency is taking this action to harmonize terminology and to improve the organization and clarity of the regulations.

This action modifies Class E airspace extending upward from 700 feet above the surface at Gratiot Community Airport, Alma, MI; Antrim County Airport, Bellaire, MI; Wexford County Airport, Cadillac, MI; Drummond Island Airport, Drummond Island, MI; Charles C. Zettel Memorial Airport, Gladwin, MI; Park Township Airport and West Michigan Regional Airport, Holland, MI; and Three Rivers Municipal Dr. Haines Airport, Three Rivers, MI. Decommissioning of non-directional radio beacons (NDB), cancellation of NDB approaches, or implementation of area navigation (RNAV) procedures have made this action necessary for the safety and management of Instrument Flight Rules (IFR) operations at the above airports. This action also updates the geographic coordinates of Three Rivers Municipal Dr. Haines Airport, and the name change of West Michigan Regional Airport (formerly Tulip City Airport) to coincide with the FAA's aeronautical database.

This action establishes Class E airspace in Park River, ND. Controlled airspace is necessary to accommodate new Standard Instrument Approach Procedures developed at Park River-W C Skjerven Field, Park River, ND, for the safety and management of Instrument Flight Rules (IFR) operations at the airport. Additionally, to correct airport name to correspond with the NASR in the header and legal description.

The U.S. Nuclear Regulatory Commission (NRC) is issuing Revision 2 to Regulatory Guide (RG) 8.10, ``Operating Philosophy for Maintaining Occupational Radiation Exposures as Low as is Reasonably Achievable.'' This revision describes methods and procedures that the NRC staff considers acceptable for maintaining radiation exposures to employees and the public as low as is reasonably achievable (ALARA).

We are adopting a new airworthiness directive (AD) for certain Continental Motors, Inc., (CMI) San Antonio (formerly known as Airmotive Engineering Corp. (AEC)), replacement parts manufacturer approval (PMA) cylinder assemblies marketed by Engine Components International Division (ECi). On July 17, 2015, AEC was purchased by CMI and is now operating as ``Continental MotorsSan Antonio.'' These cylinder assemblies are used on all CMI model -520 and -550 reciprocating engines, and on all other CMI engine models approved for the use of model -520 and -550 cylinder assemblies, such as the CMI model -470 when modified by supplemental type certificate (STC). This AD was prompted by reports of multiple cylinder head-to-barrel separations and cracked and leaking aluminum cylinder heads. This AD requires removal of the affected cylinder assemblies, including overhauled cylinder assemblies, according to a phased removal schedule. We are issuing this AD to prevent failure of the cylinder assemblies, which could lead to failure of the engine, in-flight shutdown, and loss of control of the airplane.

DoD is proposing to amend the Defense Federal Acquisition Regulation Supplement (DFARS) to implement sections of the National Defense Authorization Acts for Fiscal Years 2013 and 2016 relating to commercial item acquisitions.

The State of Arkansas has applied to the United States Environmental Protection Agency (EPA) for final authorization of the changes to its hazardous waste program under the Resource Conservation and Recovery Act (RCRA). EPA has determined that these changes satisfy all requirements needed to qualify for final authorization, and is authorizing the State's changes through this direct final rule. In the ``Proposed Rules'' section of this Federal Register, EPA is also publishing a separate document that serves as the proposal to authorize these changes. EPA believes this action is not controversial and does not expect comments that oppose it. Unless EPA receives written comments which oppose this authorization during the comment period, the decision to authorize Arkansas' changes to its hazardous waste program will take effect. If EPA receives comments that oppose this action, EPA will publish a document in the Federal Register withdrawing this direct final rule before it takes effect, and the separate document in the ``Proposed Rules'' section of this Federal Register will serve as the proposal to authorize the changes.

This document contains the final Denali Commission policies and procedures for compliance with the National Environmental Policy Act of 1969 (NEPA), as amended. This action is necessary to implement these procedures and make them available to the public on the Commission's internet site.

On June 21, 2016, the Copyright Royalty Judges (Judges) published in the Federal Register a technical amendment to regulations that govern reporting requirements for noncommercial educational webcasters that pay no more than the minimum fee for their use of sound recordings under the applicable statutory licenses. Subsequently, interested parties petitioned the Judges to amend the regulations further to effect the Judges' stated intent. The Judges' hereby publish the proposed amendment and request comments to the proposed rule.

The U.S. Army Corps of Engineers published a document in the Federal Register on May 24, 2011, amending its regulations to establish a restricted area in the Menominee River at the Marinette Marine Corporation Shipyard in Marinette, Wisconsin. The Corps published correcting amendments in the Federal Register on April 4, 2012, which corrected latitude and longitude coordinates and also revised administrative and enforcement responsibilities. The Corps is proposing to further amend these regulations to expand the existing restricted area to provide additional area of protection during the construction and launching of Littoral Combat Ships. The proposed expansion would result in temporary encroachment within the Menominee River Federal Navigation Channel. The regulations are necessary to provide adequate protection of U.S. Navy combat vessels, their materials, equipment to be installed therein, and crew, while located at the Marinette Marine Corporation Shipyard.