May 2016 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems.'' Given the relatively new presence of electronic nicotine delivery systems (ENDS) on the U.S. market and FDA's final rule deeming these products to be subject to the tobacco product authorities in the Federal Food, Drug, and Cosmetic Act (FD&C Act), FDA expects to receive premarket tobacco product application (PMTA) submissions from manufacturers of ENDS. This draft guidance is intended to assist persons with their PMTA submissions for ENDS products.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``FDA Deems Certain Tobacco Products Subject to FDA Authority, Sales and Distribution Restrictions, and Health Warning Requirements for Packages and Advertisements; Small Entity Compliance Guide.'' This small entity compliance guide (SECG) is intended to set forth in plain language the requirements of the deeming regulation and to help small businesses understand and comply with the regulation.

We propose to adopt a new airworthiness directive (AD) for all The Boeing Company Model 737-300, -400, and -500 series airplanes. This proposed AD was prompted by reports of intergranular cracks on the front spar chord lugs of the outboard horizontal stabilizer. This proposed AD would require repetitive inspections of the front spar chord lugs and lug bores of the horizontal stabilizer, and repair if necessary. We are proposing this AD to detect and correct cracking of the front spar chord lugs of the horizontal stabilizer. Such cracking could cause stabilizer instability, adversely affect controllability of the airplane, and adversely affect the structural integrity of the airplane.

The Coast Guard is establishing a temporary safety zone in the navigable waters near AT&T Park in San Francisco, CA in support of the San Francisco State University Graduation Fireworks Display on May 28, 2016. This safety zone is established to ensure the safety of mariners and spectators from the dangers associated with the pyrotechnics. Unauthorized persons or vessels are prohibited from entering into, transiting through, or remaining in the safety zone without permission of the Captain of the Port or their designated representative.

NMFS is prohibiting directed fishing for Pacific cod by catcher vessels using trawl gear in the Bering Sea and Aleutian Islands management area (BSAI). This action is necessary to prevent exceeding the B season apportionment of the 2016 Pacific cod total allowable catch allocated to trawl catcher vessels in the BSAI.

The Food and Drug Administration (FDA or we) is announcing three one-day public meetings in different regions throughout the United States to provide importers and other interested persons an opportunity to have an in-depth discussion on the implementation of the FDA Food Safety Modernization Act (FSMA) import safety programs (i.e., foreign supplier verification programs (FSVPs) for importers of food for humans and animals, accreditation of third-party certification bodies, and FDA's Voluntary Qualified Importer Program (VQIP)). During these meetings, participants and key FDA subject matter experts will discuss the next phase of FSMA implementation related to import safety programs, which includes establishing the operational framework for these programs and plans for guidance documents, training, education, and technical assistance. The purpose of the regional outreach public meetings is to continue the dialogue with the importer community on FSMA and elicit ideas that will help to inform FDA and our stakeholders on how to continue to work together to successfully comply with FSMA mandates and regulations.

This proposed rule would revise regulations for HUD's Native American and Native Hawaiian programs to incorporate existing rules that require HUD programs to be open to all eligible individuals and families regardless of sexual orientation, gender identity, or marital status. Since HUD promulgated the ``Equal Access to Housing in HUD Programs Regardless of Sexual Orientation or Gender Identity'' final rule in February, 2012, HUD has required that HUD-assisted and HUD- insured housing be made available in accordance with program eligibility requirements and without regard to sexual orientation, gender identity, or marital status, and has generally prohibited inquiries into sexual orientation or gender identity. In applying these non-discrimination requirements to HUD's Native American and Native Hawaiian programs, this proposed rule would further the Federal goal of providing decent housing and a suitable living environment for all.

The Coast Guard is issuing an interim rule to require U.S. and foreign self-propelled cargo vessels of 500 gross tons or more, traveling on international voyages and carrying cargo that is other than solid or liquid bulk cargo, to have cargo securing manuals (CSMs) on board. The rule also requires those vessels to comply with certain provisions of the International Convention for the Safety of Life at Sea, 1974 as amended (SOLAS), authorizes recognized classification societies or other approval authorities to review and approve CSMs on behalf of the Coast Guard; and prescribes when and how the loss or jettisoning of cargo at sea must be reported. The Coast Guard requests public comment on its intention to extend, in a subsequent final rule, this interim rule's requirement for vessel CSMs to self-propelled cargo vessels under 500 gross tons, if these vessels carry dangerous goods in packaged form on international voyages. This interim rule promotes the Coast Guard's maritime safety and stewardship (environmental protection) missions, helps fulfill U.S. treaty obligations, and could help prevent or mitigate the consequences of vessel cargo loss.

We are adopting a new airworthiness directive (AD) for certain The Boeing Company Model 737-300, -400, and -500 series airplanes. This AD was prompted by reports of fatigue cracking found at the left-side and right-side upper frames, at a certain area. This AD requires repetitive medium frequency eddy current (MFEC) inspections for cracking of the left-side and right-side upper frames, and repair (including open hole high frequency eddy current (HFEC) inspections for cracking of fastener holes) if necessary. This AD also provides an optional preventive modification, which terminates the repetitive inspections at the modified location. We are issuing this AD to detect and correct fatigue cracking of the upper frame, which can grow in size and result in a severed frame, leading to rapid decompression and consequent reduced structural integrity of the airplane.

The Coast Guard is amending its safety zones regulation for Annual Events in the Captain of the Port Lake Michigan zone. This amendment updates 18 permanent safety zones and adds 3 new permanent safety zones. These amendments and additions are necessary to protect spectators, participants, and vessels from the hazards associated with annual maritime events, including fireworks displays, boat races, and air shows.

Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) repeals the Medicare sustainable growth rate (SGR) methodology for updates to the physician fee schedule (PFS) and replaces it with a new Merit-based Incentive Payment System (MIPS) for MIPS eligible clinicians or groups under the PFS. This proposed rule would establish the MIPS, a new program for certain Medicare-enrolled practitioners. MIPS would consolidate components of three existing programs, the Physician Quality Reporting System (PQRS), the Physician Value-based Payment Modifier (VM), and the Medicare Electronic Health Record (EHR) Incentive Program for Eligible Professionals (EPs), and would continue the focus on quality, resource use, and use of certified EHR technology (CEHRT) in a cohesive program that avoids redundancies. This proposed rule also would establish incentives for participation in certain alternative payment models (APMs) and includes proposed criteria for use by the Physician-Focused Payment Model Technical Advisory Committee (PTAC) in making comments and recommendations on physician-focused payment models. In this proposed rule we have rebranded key terminology based on feedback from stakeholders, with the goal of selecting terms that would be more easily identified and understood by our stakeholders.

The Environmental Protection Agency (EPA) is proposing to partially approve and partially disapprove a revision to the Louisiana State Implementation Plan (SIP) submitted by the State of Louisiana on December 21, 2011. This revision outlines the State's program to regulate and permit emissions of greenhouse gases (GHGs) in the Louisiana Prevention of Significant Deterioration (PSD) program. We are proposing to approve those provisions to the extent that they address the GHG permitting requirements for sources already subject to PSD for pollutants other than GHGs. We are proposing to disapprove those provisions to the extent they require PSD permitting for sources that emit only GHGs above the thresholds triggering the requirement to obtain a PSD permit since that is no longer consistent with federal law. The EPA is proposing this action under section 110 and part C of the Clean Air Act (CAA or Act).

The United States Patent and Trademark Office (USPTO) issued the July 2015 Update: Subject Matter Eligibility (July 2015 Update) to provide further guidance to examiners in determining subject matter eligibility under 35 U.S.C. 101. The USPTO announced the July 2015 Update in the Federal Register, and sought public comment on the July 2015 Update. The USPTO has since issued a memorandum to the Patent Examining Corps titled ``Formulating a Subject Matter Eligibility Rejection and Evaluating the Applicant's Response to a Subject Matter Eligibility Rejection'' in response to those public comments, which is available to the public on the USPTO's Internet Web site. The memorandum seeks to improve examiner correspondence with regard to subject matter eligibility rejections. Further, additional life science examples to assist examiners in making eligibility determinations have been published and are available on the USPTO's Internet Web site. The USPTO is now seeking public comment on subject matter eligibility on an on-going basis.

This document contains proposed regulations that set forth the Federal employment tax liabilities and other obligations of persons certified by the IRS as certified professional employer organizations (CPEOs) in accordance with provisions enacted as part of The Stephen Beck, Jr., Achieving a Better Life Experience Act of 2014. The proposed regulations also propose to adopt, by cross-reference, the text of temporary regulations in the Rules and Regulations section of this issue of the Federal Register, which relate to the requirements for applying for, receiving, and maintaining certification as a CPEO. These proposed regulations will affect persons who apply to be treated as CPEOs and who are certified by the IRS as meeting the applicable requirements. In certain instances, the proposed regulations will also affect the federal employment tax liabilities and other obligations of customers of the CPEO.

The Agency published a document in the Federal Register of January 14, 2016 at 81 FR 1861 establishing a technical assistance and training grant program for qualified public bodies, nonprofit corporations, and federally recognized tribes and Indian Tribes on Federal and State Reservations that will serve rural areas for the purpose of enabling the grantees to provide technical assistance and training with respect to essential community facilities authorized under section 306(a)(1) of the CONACT (7 U.S.C. 1926(a)) This document has an incorrect cross-reference and an ineligible project purpose which needs to be removed due to the publication of the new 7 CFR part 1970 regulations.

The Coast Guard proposes to modify the operating schedule for all drawbridges over the Fox River between DePere, WI and Oshkosh, WI. A review of the current regulation was requested by the Wisconsin Department of Transportation and the Fox River Navigational System Authority.

This action amends the airspace designation and airport name in Class E airspace by changing the designation from Cherokee Village Airport, AR, to Ash Flat, AR; and changing the airport name from Cherokee Village Airport to Sharp County Village Airport, Ash Flat, AR. These changes reflect the current information in the FAAs aeronautical database.

This action proposes to establish Class E en route domestic airspace in the Linton Municipal Airport, Linton, ND area, to facilitate vectoring of Instrument Flight Rules (IFR) aircraft under control of Minneapolis Air Route Traffic Control Center (ARTCC). The FAA is proposing this action to enhance the safety and efficiency of aircraft operations within the National Airspace System (NAS).

This action proposes to establish Class E en route domestic airspace in the Harvey Municipal Airport, Harvey, ND area, to facilitate vectoring of Instrument Flight Rules (IFR) aircraft under control of Minneapolis Air Route Traffic Control Center (ARTCC). The FAA is proposing this action to enhance the safety and efficiency of aircraft operations within the National Airspace System.

The Office of Personnel Management (OPM) proposes to amend part 297 of title 5, Code of Federal Regulations, to implement a 60-day timeframe for individuals to appeal or submit requests for administrative review of initial decisions regarding access and amendment requests involving records maintained in OPM systems of records. This proposed change will allow greater efficiency in processing appeals and requests for administrative review and will also improve the office's records maintenance and disposal policies. OPM's retention of the Privacy Act Case Records are to be maintained in accordance with the NARA General Records Schedule 14 which relies on whether or not the request is appealed to institute a disposal timeframe. The addition of this appeal or administrative review timeframe will allow offices to dispose of records in accordance with the NARA General Records Schedule 14. OPM is also proposing to update the points of contact for Privacy Act matters, including where to address appeals or requests for administrative review of access and amendment denials involving records maintained in OPM systems of records. OPM also proposes to amend part 297 of title 5, Code of Federal Regulations to implement exemptions for the OPM Central-9/Personnel Investigations Records, the OPM Internal 16/Adjudications Officer Control Files, the newly established OPM Internal 20/Integrity Assurance Officer Control Files, and the newly established OPM Internal 19/Investigative Training Records. In this proposed rulemaking, OPM proposes to exempt portions of these system of records from one or more provisions of the Privacy Act to safeguard national security information, and law enforcement information, to protect the identities of sources who furnished information under an express promise of confidentiality, and to safeguard qualifications testing and examination materials that would, if released, compromise the objectivity or fairness of the testing or examination process.

This NPRM proposes a new Federal Motor Vehicle Safety Standard (FMVSS) No. 217a, ``Anti-ejection glazing for bus portals,'' to drive the installation of advanced glazing in high-occupancy buses (generally, over-the-road buses (of any weight) and non-over-the-road buses with a gross vehicle weight rating greater than 11,793 kilograms (26,000 pounds). The new standard would specify impactor testing of glazing material. In the tests, a 26 kilogram (57 pound) impactor would be propelled from inside a test vehicle toward the window glazing at 21.6 kilometers/hour (13.4 miles per hour). The impactor and impact speed would simulate the loading from an average size unrestrained adult male impacting a window on the opposite side of a large bus in a rollover. Performance requirements would apply to side and rear windows, and to glass panels and windows on the roof to mitigate partial and complete ejection of passengers from these windows and to ensure that emergency exits remain operable after a rollover crash. NHTSA also proposes to limit the protrusions of emergency exit latches into emergency exit openings of windows to ensure they do not unduly hinder emergency egress. This NPRM is among the rulemakings issued pursuant to NHTSA's 2007 Approach to Motorcoach Safety and DOT's Departmental Motorcoach Safety Action Plan. In addition, to the extent warranted under the National Traffic and Motor Vehicle Safety Act, establishing advanced glazing standards for the side and rear portals of the subject buses would fulfill a statutory provision of the Motorcoach Enhanced Safety Act of 2012 (incorporated and passed as part of the Moving Ahead for Progress in the 21st Century Act).

We are superseding airworthiness directive (AD) 2013-08-17 for Airbus Helicopters Model SA-365N, SA-365N1, AS-365N2, AS 365 N3, and SA-366G1 helicopters. AD 2013-08-17 required initial and recurring inspections of the 9-degree fuselage frame for a crack and repairing the frame if a crack exists. This new AD modifies the compliance times and expands the inspection area of the 9-inch frame. The actions of this AD are intended to detect a crack in the 9-degree frame to prevent loss of structural integrity and subsequent loss of control of the helicopter.

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 airspeed indication discrepancies while flying at high altitudes in inclement weather. This AD requires replacing certain pitot probes on the captain, first officer, and standby sides with certain new pitot probes. We are issuing this AD to prevent airspeed indication discrepancies during inclement weather, which, depending on the prevailing altitude, could lead to unknown accumulation of ice crystals and consequent reduced controllability of the airplane.

This regulation establishes time-limited tolerances for residues of methoxyfenozide in or on rice, grain and rice, bran resulting from use of methoxyfenozide in accordance with the terms of an emergency exemption issued under section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). This action is in response to the California Department of Pesticide Regulation's issuance of a crisis emergency exemption under FIFRA section 18 authorizing use of the pesticide on rice, bran and rice, grain. This time-limited tolerance regulation establishes a maximum permissible level for residues of methoxyfenozide in or on these commodities. These time-limited tolerances expire on December 31, 2019.

In this document, the Federal Communications Commission (FCC or Commission) revises its rules governing the Emergency Alert System (EAS) to incorporate new multilingual alerting reporting requirements into its State EAS Plan reporting requirements. The Commission takes this action in response to a Petition for Immediate Interim Relief (Petition) jointly filed by the Independent Spanish Broadcasters Association (ISBA), the Office of Communication of the United Church of Christ, Inc., and the Minority Media and Telecommunications Council (now called The Multicultural, Media, Telecom and Internet Council) (MMTC) (collectively, ``Petitioners'').